The following data is part of a premarket notification filed by Instratek, Inc. with the FDA for Hav-lok Bunion Correction System.
| Device ID | K082384 |
| 510k Number | K082384 |
| Device Name: | HAV-LOK BUNION CORRECTION SYSTEM |
| Classification | Washer, Bolt Nut |
| Applicant | INSTRATEK, INC. 210 SPRINGHILL DR. SUITE 130 Spring, TX 77386 |
| Contact | Jeff Seavey |
| Correspondent | Jeff Seavey INSTRATEK, INC. 210 SPRINGHILL DR. SUITE 130 Spring, TX 77386 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-19 |
| Decision Date | 2008-12-08 |
| Summary: | summary |