Updated 22 October 2026
Orthopaedic and spine device distributors in South Korea: 74 licensed establishments
The Bastion Hale Distributor Index lists 74 establishments in South Korea whose registry records include orthopaedics, spine and trauma: 1 with a channel role (importer, distributor, wholesaler or authorised representative), 13 registration holders without a channel role, and 60 registered as manufacturer or exporter only, out of 862 medical device establishments in South Korea overall. The records come from US FDA (openFDA) and Health Canada, last seen on 22 October 2026.
Orthopaedics covers implants for joints, spine and trauma, together with instruments and bone substitutes. Implants are usually Class IIb or III, so the importer or registration holder carries real regulatory work and hospitals often buy through tenders. Distributors in this segment tend to employ clinical support staff who attend surgery.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Distributor | 1 | 1% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 14 | 19% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 69 | 93% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 16 | 22% | Registered with the US FDA as an exporter of devices made for export. |
An establishment can hold several roles, so the shares add to more than 100%.
Who holds the registration in South Korea
In South Korea the MFDS approval is held by a Korea Licence Holder, which is usually the importer. Changing importer means transferring or re-filing the approval, so many manufacturers appoint an independent holder.
Top 20 orthopaedics, spine and trauma establishments by size
Channel roles first, then registration holders, then manufacturers. Size is a 0 to 100 score; Complete is 0 to 5.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | OSSTEM IMPLANT CO., LTD. Haeundae-gu Busan, GD | Channel Distributor, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Dental, Ear, nose and throat +3 more | 358 | 41 | 0 | 65.6 | 3/5 |
| 2 | Megagen Implant Co., Ltd. Daegu | Holder Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Dental, Orthopaedics, spine and trauma +2 more | 233 | 25 | 0 | 59.9 | 3/5 |
| 3 | DIO Corporation Haeundae-gu Busan | Holder Registration holder, Manufacturer, Exporter | Dental, Ear, nose and throat, Orthopaedics, spine and trauma +2 more | 202 | 27 | 0 | 59.6 | 3/5 |
| 4 | JEIL MEDICAL CORPORATION Seoul | Holder Registration holder, Manufacturer | General hospital and consumables, Dental, Ear, nose and throat +4 more | 128 | 12 | 0 | 52.0 | 3/5 |
| 5 | DENTIUM CO., LTD. Suwon-si Gyeonggi | Holder Registration holder, Manufacturer | Dental, Ear, nose and throat, Orthopaedics, spine and trauma +1 more | 87 | 10 | 0 | 49.3 | 3/5 |
| 6 | COWELLMEDI CO., LTD. BUSAN | Holder Registration holder, Manufacturer | Dental, Ear, nose and throat, Orthopaedics, spine and trauma +1 more | 79 | 6 | 0 | 46.7 | 3/5 |
| 7 | INNOBIOSURG CO., LTD. Daejeon | Holder Registration holder, Manufacturer | Dental, Orthopaedics, spine and trauma | 58 | 4 | 0 | 43.6 | 3/5 |
| 8 | INBODY CO., LTD. Cheonan-si Chungnam | Holder Registration holder, Manufacturer | Cardiovascular, General hospital and consumables, In-vitro diagnostics +3 more | 19 | 9 | 0 | 41.4 | 3/5 |
| 9 | IMEDICOM CO., LTD. Gunpo-si Gyeonggi, GD | Holder Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Orthopaedics, spine and trauma, Surgery and endoscopy | 25 | 2 | 0 | 38.6 | 3/5 |
| 10 | DENTOS, INCORPORATED DAEGU | Holder Registration holder, Manufacturer | Dental, Orthopaedics, spine and trauma | 11 | 7 | 0 | 37.7 | 3/5 |
| 11 | NIBEC CO., LTD. Jincheon-gun Chungbuk | Holder Registration holder, Manufacturer | General hospital and consumables, Dental, Orthopaedics, spine and trauma | 12 | 5 | 0 | 36.8 | 3/5 |
| 12 | GNI Co., LTD Hwaseong-si Gyeonggi, GD | Holder Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Dental, Orthopaedics, spine and trauma | 22 | 2 | 0 | 36.4 | 3/5 |
| 13 | PURGO BIOLOGICS INC. Seongnam-si Gyeonggi, GD | Holder Registration holder, Manufacturer | Dental, Orthopaedics, spine and trauma, Surgery and endoscopy | 6 | 7 | 0 | 35.0 | 3/5 |
| 14 | HANSBIOMED CORP. Daejeon | Holder Registration holder, Manufacturer | Orthopaedics, spine and trauma | 14 | 2 | 0 | 30.8 | 3/5 |
| 15 | Zimmer Biomet Korea Ltd. Seoul | Manufacturer Exporter | General hospital and consumables, Gastroenterology, urology and OB/GYN, Patient monitoring and neurology +2 more | 650 | 1 | 0 | 45.8 | 3/5 |
| 16 | L&K BIOMED CO.,LTD. Yongin-SI Gyeonggi | Manufacturer Manufacturer, Exporter | In-vitro diagnostics, Patient monitoring and neurology, Orthopaedics, spine and trauma +1 more | 95 | 1 | 0 | 38.3 | 3/5 |
| 17 | CORENTEC CO., LTD. Cheonan Si, Chungnam | Manufacturer Manufacturer, Exporter | Orthopaedics, spine and trauma, Surgery and endoscopy | 74 | 1 | 0 | 37.1 | 3/5 |
| 18 | Arthrex Korea Ltd. Gangnam-gu Seoul | Manufacturer Exporter | General hospital and consumables, Gastroenterology, urology and OB/GYN, Orthopaedics, spine and trauma +2 more | 101 | 1 | 0 | 36.4 | 3/5 |
| 19 | OSTEONIC CO., LTD. Seoul | Manufacturer Manufacturer, Exporter | Dental, In-vitro diagnostics, Patient monitoring and neurology +2 more | 38 | 1 | 0 | 33.8 | 3/5 |
| 20 | CG MedTech Co., Ltd. Uijeongbu-si Gyeonggi | Manufacturer Manufacturer | Patient monitoring and neurology, Orthopaedics, spine and trauma, Surgery and endoscopy | 56 | 1 | 0 | 33.4 | 3/5 |
Questions about orthopaedics, spine and trauma distributors in South Korea
How many orthopaedics, spine and trauma distributors are there in South Korea?
The Index counts 74 establishments in South Korea with orthopaedics, spine and trauma in their registry record, of which 1 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from US FDA (openFDA) and Health Canada and was last refreshed on 22 October 2026.
Who can hold a orthopaedics, spine and trauma device registration in South Korea?
In South Korea the MFDS approval is held by a Korea Licence Holder, which is usually the importer. Changing importer means transferring or re-filing the approval, so many manufacturers appoint an independent holder.
How do I find a orthopaedics, spine and trauma distributor in South Korea?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and South Korea to reveal three profiles. For a ranked shortlist for your device, get the Next 10 Markets report.
What does the Distributor Index count as a orthopaedics, spine and trauma distributor in South Korea?
A company that appears in a public regulatory registry with an address in South Korea and whose linked device listings fall in the orthopaedics, spine and trauma segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
Other segments in South Korea
Orthopaedics, spine and trauma in other Asia Pacific markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 73 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 14 establishments, last seen 22 October 2026. Contains information licensed under the Open Government Licence, Canada.
Index build 22 October 2026. Each establishment is counted once per country after resolving names across sources. Named individuals are never collected.
Registry data. Bastion Hale does not vouch for any establishment.