510(k) K041115 ยท JDR Staple, Fixation, Bone
GII QUICKANCHOR PLUS
| Applicant | Depuy Mitek, A Johnson & Johnson Company, Norwood MA, US |
| Decision | Substantially Equivalent, May 28, 2004 |
| Received | Apr 29, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041115
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2. Ref. 212034 Lot 123266
General and Plastic Surgery Terminated |
GAS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.