510(k) K223538
- Device
- Integrity Implant
- Applicant
- Anika Therapeutics, Inc.
- 510(k) number
- K223538
- Product code
- OWX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-08-17
- Date received
- 2022-11-23
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Wei Zhao
- Address
- 32 Wiggins Ave. Beford MA US 01730 01730
FDA Registration Numbers#
- 3007093114
- 3034932459
- 3007109793
- 3010331645
- 3002807315
- 1220477
- 3006946276
- 3015231789
- 3032412536
- 1220246
- 3007663067
- 8044102
- 3008793310
- 3006017180
Source Documents#
Other 510(k) Records For Product Code OWX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253867 | FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit | ZuriMED Technologies AG | 2026-01-02 |
| K250997 | Integrity™ Implant | Anika Therapeutics, Inc. | 2025-06-17 |
| K243480 | SuturePatch Tissue Reinforcement | Arthrex, Inc. | 2025-05-29 |
| K241219 | FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) | ZuriMED Technologies AG | 2024-12-11 |