The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Minimally Invasive Solutions Osteotomy Guide Instrument.
| Device ID | K033652 |
| 510k Number | K033652 |
| Device Name: | MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Stephen Mckelvey |
| Correspondent | Stephen Mckelvey ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-20 |
| Decision Date | 2004-02-04 |
| Summary: | summary |