510(k) K043310 ยท HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Jan 5, 2005 |
| Received | Dec 1, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043310
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2016 | Synthes (USA) Products LLC Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm
Non-Sterile Terminated |
HWE | None listed |
| Sep 27, 2016 | The Anspach Effort, Inc. Light Adaptor for Small Battery Drive and Small Battery Drive II. Terminated |
HWE | None listed |
| Sep 27, 2016 | The Anspach Effort, Inc. Adaptor for Small Battery Drive and Small Battery Drive II.
Product Usage:
The Light Adaptor for Small Battery Drive (SBD) /Small Battery Drive II (SBD II) is designed for use in traumatology and ort Terminated |
HWE | None listed |
| Jul 12, 2016 | Synthes (USA) Products LLC Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001
Product Usage:
The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist wit Terminated |
HWE | None listed |
| Mar 23, 2015 | Synthes, Inc. Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smo Terminated |
HWE | None listed |
| Dec 31, 2013 | Synthes USA HQ, Inc. Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012
The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decort Terminated |
HWE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.