Cove Putty, OsteoCove Putty
FDA 510(k) clearance K242273 · decided 2024-09-25
Clearance details
- K-number
- K242273
- Device name
- Cove Putty, OsteoCove Putty
- Applicant
- SeaSpine Orthopedics Corporation
- Decision
- Substantially Equivalent
- Date received
- 2024-08-01
- Decision date
- 2024-09-25
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Dem recall (Z-0955-2025) | IsoTis OrthoBiologics, Inc. | 2025-01-16 |
| OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01. recall (Z-0919-2025) | IsoTis OrthoBiologics, Inc. | 2025-01-15 |