REGEN COLLAGEN SCAFFOLD (CS)
FDA 510(k) clearance K082079 · decided 2008-12-18
Clearance details
- K-number
- K082079
- Device name
- REGEN COLLAGEN SCAFFOLD (CS)
- Applicant
- Regen Biologics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-07-23
- Decision date
- 2008-12-18
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- OLC
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Hackensack, NJ, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
| RejuvaKnee™ Collagen Meniscus Implant (K242302) | Collagen Matrix, Inc. | 2024-10-02 |
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Recalls involving this device
No recalls on record reference this clearance.