510(k) K140414 ยท LXH Orthopedic Manual Surgical Instrument
IMBIBE NEEDLE
| Applicant | Orthovita, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Apr 1, 2014 |
| Received | Feb 18, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140414
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2015 | Orthovita, Inc., dBA Stryker Orthobiologics. Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: 2090-0027 Needle (bullet-tip), 11 gauge x 4 inch
2090-0028 Needle (bullet-tip), 11 gauge x 6 inch
2090-0029 Needle (bullet- Terminated |
KNW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.