510(k) K123942 ยท NDN Cement, Bone, Vertebroplasty
STRYKER IVAS BALLOON CATHETER
| Applicant | Stryker Corporation, Kalamazoo MI, US |
| Decision | Substantially Equivalent, Apr 3, 2013 |
| Received | Dec 20, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123942
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 9, 2017 | Stryker Instruments Div. of Stryker Corporation 10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830
for spinal orthopedic use. Terminated |
NDN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.