Panels › General, Plastic Surgery › Product code OWW · Class 2
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Regulation 878.3300
0510(k)s in 12 months (10 all time)
3recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in OWW
| Company | 510(k)s | Recalls |
|---|---|---|
| International Life Sciences | 1 | 3 |
| Alafair Biosciences | 3 | 0 |
| Conmed Corporation | 2 | 0 |
| Biorez, Inc. | 1 | 0 |
| Celestray Biotech Company, LLC., | 1 | 0 |
| Nanofiber Solutions, LLC | 1 | 0 |
| Soft Tissue Regeneration, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 18, 2025 | K251655 | VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) Alafair Biosciences | OWW |
| Feb 27, 2025 | K250021 | Rotium Nanofiber Solutions, LLC | OWW |
| Nov 27, 2024 | K242187 | BioBrace® Conmed Corporation | OWW |
| Jul 29, 2024 | K241906 | BioBrace® Reinforced Implant Conmed Corporation | OWW |
| Jun 14, 2024 | K240817 | VersaWrap Alafair Biosciences, Inc. | OWW |
| Jul 6, 2023 | K222220 | SpinMedix Absorbable Fibrous Membrane Celestray Biotech Company, LLC., | OWW |
| May 26, 2023 | K230316 | FlexBand; FlexPatch; FlexBand Plus International Life Sciences | OWW |
| Apr 30, 2021 | K203267 | The BioBrace Implant Biorez, Inc. | OWW |
| Jun 10, 2016 | K160364 | VersaWrap Tendon Protector Alafair Biosciences, Inc. | OWW |
| Nov 21, 2012 | K121216 | STR GRAFT Soft Tissue Regeneration, Inc. | OWW |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.