510(k) K103243 ยท HRS Plate, Fixation, Bone
2.4MM VA-LCP INTERCARPAL FUSION SYSTEM
| Applicant | Synthes (Usa), West Chester PA, US |
| Decision | Substantially Equivalent, Jan 21, 2011 |
| Received | Nov 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103243
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2019 | Synthes, Inc. 2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field. Terminated |
HRS | None listed |
| Dec 16, 2019 | Synthes, Inc. 2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field. Terminated |
HRS | None listed |
| Dec 16, 2019 | Synthes, Inc. 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field. Terminated |
HRS | None listed |
| Dec 16, 2019 | Synthes, Inc. 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field. Terminated |
HRS | None listed |
| Dec 16, 2019 | Synthes, Inc. 2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field. Terminated |
HRS | None listed |
| Aug 11, 2016 | Synthes (USA) Products LLC Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone, Orthopedic Devices
Terminated |
HRS | None listed |
| Nov 2, 2015 | Synthes (USA) Products LLC 2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.