510(k) K172130 ยท MQV Filler, Bone Void, Calcium Compound
Resorbable Mesh Device
| Applicant | SeaSpine Orthopedics Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Nov 16, 2017 |
| Received | Jul 14, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172130
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2026 | IsoTis OrthoBiologics, Inc. OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095.
Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095 Open, Classified |
MQV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.