Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Instratek with 10 510(k) clearances and 3 device recalls. The most recent is a device recall dated Nov 24, 2015: Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopi….
| Date | Record | Source |
|---|---|---|
| Nov 24, 2015 | Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.Class II · The sterile blade will not fit into the handle provided with the ETTD system. | Device recalls |
| Feb 6, 2014 | STAPIX SUPERELASTIC IMPLANT BONE STAPLESK133523 · JDR | 510(k) clearances |
| Jul 25, 2013 | JONES-FX FRACTURE SYSTEMK131620 · HWC | 510(k) clearances |
| Apr 25, 2013 | 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/SystemClass II · Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set. | Device recalls |
| Sep 18, 2012 | Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger releaClass II · Instratek, Inc.has received multiple complaints of the 1052 Trigger Finger Release Blades which could not be advanced in | Device recalls |
| May 17, 2012 | MINI CANNULATED HEADED AND HEADLESS SCREW SETK120493 · HWC | 510(k) clearances |
| Aug 31, 2011 | CMC CABLE FIXK111032 · HTN | 510(k) clearances |
| Aug 14, 2009 | MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000K091763 · HTN | 510(k) clearances |
| Dec 8, 2008 | HAV-LOK BUNION CORRECTION SYSTEMK082384 · HTN | 510(k) clearances |
| Mar 14, 2008 | SUB-TALAR LOK, MODEL 7-11 MMK080280 · HWC | 510(k) clearances |
| Dec 12, 1994 | ENDOSCOPIC MORTONS NEUROMA INSTRUMENTSK940230 · HRX | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
