Panels › Orthopedic › Product code HTQ · Class 1
Broach
Regulation 888.4540
0510(k)s in 12 months (0 all time)
0recalls in 12 months (5 all time)
0recalls that name a 510(k)
Top companies in HTQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer Inc. | 0 | 2 |
| Encore Medical, Lp | 0 | 1 |
| Greatbatch Medical | 0 | 1 |
| Stryker Howmedica Osteonics Corp. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2017 | Greatbatch Medical Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and EZ Clean" Linear Broach Handle Greatbatch Part # T11824, DJO Surgical Inc. # 803-03-059). Terminated |
HTQ | None listed |
| Jul 5, 2011 | Encore Medical, Lp Foundation Knee System Instrumentation, Tibial Broach Assembly.
Used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected tibial plateau for acceptance of a Terminated |
HTQ | None listed |
| Jul 7, 2009 | Zimmer Inc. Zimmer TM-400 Broach Handle; Part No. 96-210-10001. The product is a surgical instrument for use in conjunction with Zimmer TM-400 Trabecular Metal implants during spinal surgery.
The Broach Handle Terminated |
HTQ | None listed |
| May 12, 2009 | Zimmer Inc. Zimmer Nexgen Complete Knee Solution Fluted Stemmed Tibial Broach, Size 7, 8, nonsterile; REF 5997-61-07.
A reusable cutting instrument that is used in total knee arthroplasty surgery. Terminated |
HTQ | None listed |
| Sep 19, 2008 | Stryker Howmedica Osteonics Corp. Rejuvenate Broach
Catalog No: 1601-1005, 1601-1006, 1601-1007, 1601-1008, 1601-1009, 1601-1010
Stryker Orthopaedics,
Mahwah, NJ. 07430
Contours the proximal femur to the geometry of the stem to provi Terminated |
HTQ | None listed |
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