Company ยท US
Instratek, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2014. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 6, 2014 | K133523 | STAPIX SUPERELASTIC IMPLANT BONE STAPLES Instratek, Inc. | JDR |
| Jul 25, 2013 | K131620 | JONES-FX FRACTURE SYSTEM Instratek, Inc. | HWC |
| May 17, 2012 | K120493 | MINI CANNULATED HEADED AND HEADLESS SCREW SET Instratek, Inc. | HWC |
| Aug 31, 2011 | K111032 | CMC CABLE FIX Instratek, Inc. | HTN |
| Aug 14, 2009 | K091763 | MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000 Instratek, Inc. | HTN |
| Dec 8, 2008 | K082384 | HAV-LOK BUNION CORRECTION SYSTEM Instratek, Inc. | HTN |
| Mar 14, 2008 | K080280 | SUB-TALAR LOK, MODEL 7-11 MM Instratek, Inc. | HWC |
| Dec 12, 1994 | K940230 | ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS Instratek, Inc. | HRX |
| Apr 27, 1993 | K925083 | ENDOTRAK SYSTEM Instratek, Inc. | HRX |
| Aug 18, 1992 | K922391 | ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS Instratek, Inc. | HRX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2015 | Instratek, Incorporated Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System. Terminated |
HRX | None listed |
| Sep 22, 2014 | Instratek, Incorporated Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System Terminated |
HWC | K120493 |
| Mar 8, 2013 | Instratek, Incorporated Endotrig Trigger Release Sterile Micro Hook Blade
Product Usage:
The blade is intended to release A-1 pulley in endoscopic trigger release procedures. Terminated |
NBH | None listed |