510(k) K011335 ยท HRS Plate, Fixation, Bone
SYNTHS ONE-THIRD TUBULAR DCL PLATE
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Jul 27, 2001 |
| Received | May 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011335
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2020 | Synthes (USA) Products LLC DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, ra Terminated |
HRS | None listed |
| Jun 19, 2013 | Synthes USA HQ, Inc. Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011 Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.