SuturePatch Tissue Reinforcement
FDA 510(k) clearance K243480 · decided 2025-05-29
Clearance details
- K-number
- K243480
- Device name
- SuturePatch Tissue Reinforcement
- Applicant
- Arthrex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-11-08
- Decision date
- 2025-05-29
- Days to decision
- 202 days
- Clearance type
- Traditional
- Product code
- OWX
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Naples, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit (K253867) | ZuriMED Technologies AG | 2026-01-02 |
| Integrity™ Implant (K250997) | Anika Therapeutics, Inc. | 2025-06-17 |
| FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) (K241219) | ZuriMED Technologies AG | 2024-12-11 |
| Integrity Implant (K223538) | Anika Therapeutics, Inc. | 2023-08-17 |
Recalls involving this device
No recalls on record reference this clearance.