510(k) K141385 ยท HBW Fastener, Plate, Cranioplasty
DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)
| Applicant | Depuy Synthes Companies of Johnson & Johnson, West Chester PA, US |
| Decision | Substantially Equivalent, Mar 27, 2015 |
| Received | May 27, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141385
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2024 | Synthes (USA) Products LLC RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and Open, Classified |
HBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.