The following data is part of a premarket notification filed by Instratek, Inc. with the FDA for Sub-talar Lok, Model 7-11 Mm.
| Device ID | K080280 |
| 510k Number | K080280 |
| Device Name: | SUB-TALAR LOK, MODEL 7-11 MM |
| Classification | Screw, Fixation, Bone |
| Applicant | INSTRATEK, INC. 210 SPRING HILL DR. SUITE 130 The Woodlands, TX 77386 |
| Contact | Jeff Seavey |
| Correspondent | Jeff Seavey INSTRATEK, INC. 210 SPRING HILL DR. SUITE 130 The Woodlands, TX 77386 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-04 |
| Decision Date | 2008-03-14 |
| Summary: | summary |