Data / Medical devices / Instruments Designed For Press-Fit Osteochondral Implants
Instruments Designed For Press-Fit Osteochondral Implants (QBO): 10 FDA-registered makers in 5 countries
10 establishments in 5 countries are registered with the FDA to make Instruments Designed For Press-Fit Osteochondral Implants (product code QBO, Class 2, 21 CFR 888.4505). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on September 4, 2019, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QBO
- Device class
- 2
- Regulation
- 888.4505
- Medical specialty
- Orthopedic
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Israel | 2 |
| Ireland | 2 |
| United Kingdom | 1 |
| China | 1 |
Makers of Instruments Designed For Press-Fit Osteochondral Implants
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cartiheal Ltd. | Kfar Saba Central, Israel | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy (ireland) | CO. CORK Munster, Ireland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Intl., Ltd. | Leeds, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Orthopaedics, Inc. | Warsaw, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Ireland UC | Co. Cork Munster, Ireland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Aquila Precise Tools Limited | Guangzhou City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical, Inc. | Pierceton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Skeletal Dynamics, Inc | Miami, FL, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Swami Medical | Del Mar, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| T.A.G. Medical Products Corporation Ltd | GAATON Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 4, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.