The following data is part of a premarket notification filed by Instratek, Inc. with the FDA for Michelangelo Bunion System - Mabs, Model: Ma6000.
| Device ID | K091763 |
| 510k Number | K091763 |
| Device Name: | MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-16 |
| Decision Date | 2009-08-14 |
| Summary: | summary |