510(k) K242273 ยท MQV Filler, Bone Void, Calcium Compound
Cove Putty, OsteoCove Putty
| Applicant | SeaSpine Orthopedics Corporation, Carlsbad CA, US |
| Decision | Substantially Equivalent, Sep 25, 2024 |
| Received | Aug 1, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242273
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2025 | IsoTis OrthoBiologics, Inc. OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100. Open, Classified |
MQV | None listed |
| Jan 15, 2025 | IsoTis OrthoBiologics, Inc. OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01. Open, Classified |
MQV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.