510(k) K142292 ยท JDR Staple, Fixation, Bone
Speed, Speed Shift, Speed Titan, Speed Arc
| Applicant | Biomedical Enterprises, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Nov 17, 2014 |
| Received | Aug 18, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142292
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2022 | Synthes (USA) Products LLC SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and management of fracture and re Open, Classified |
JDR | None listed |
| Oct 18, 2022 | Synthes (USA) Products LLC SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512 Open, Classified |
JDR | None listed |
| Oct 18, 2022 | Synthes (USA) Products LLC SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910 Open, Classified |
JDR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.