Instratek, Incorporated
Houston, TX, US
Instratek, Incorporated appears in FDA device records in Houston, TX. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 3
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0469-2016 | Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System. | The sterile blade will not fit into the handle provided with the ETTD system. | Class II | Terminated | |
| Z-2679-2014 | 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 | Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set. | Class II | Terminated | |
| Z-0922-2013 | Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures. | Instratek, Inc.has received multiple complaints of the 1052 Trigger Finger Release Blades which could not be advanced into the cannula through which it is used during trigger finger release procedures. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain