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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2026 | International Life Sciences Artelon FLEXBAND TWIST .12
Ref: TW012
3.85x17mm HEX Anchor (Qty 2)
5.0x17mm HEX Anchor (Qty 1)
0.5x12cm FLEXBAND (Qty 1) Open, Classified |
OWW | K200503 K230316 |
| Mar 11, 2026 | International Life Sciences Artelon FlexBand Plus
Ref: 41054 & 41057 Open, Classified |
OWW | K230316 |
| Mar 11, 2026 | International Life Sciences Artelon FlexBand Dynamic Matrix
Ref: 31057 Open, Classified |
OWW | K200503 K230316 |
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