RejuvaKnee™ Collagen Meniscus Implant
FDA 510(k) clearance K242302 · decided 2024-10-02
Clearance details
- K-number
- K242302
- Device name
- RejuvaKnee™ Collagen Meniscus Implant
- Applicant
- Collagen Matrix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-08-05
- Decision date
- 2024-10-02
- Days to decision
- 58 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
- Oakland, NJ, 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 |
|---|---|---|
| Collagen Meniscus Implant XL (K170364) | Ivy Sports Medicine, LLC | 2017-05-02 |
| REGEN COLLAGEN SCAFFOLD (CS) (K082079) | Regen Biologics, Inc. | 2008-12-18 |
Recalls involving this device
No recalls on record reference this clearance.