The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Ortho Guidance Systems- Hip Instruments.
| Device ID | K033223 |
| 510k Number | K033223 |
| Device Name: | ZIMMER ORTHO GUIDANCE SYSTEMS- HIP INSTRUMENTS |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Karen Cain |
| Correspondent | Karen Cain ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-06 |
| Decision Date | 2004-02-18 |
| Summary: | summary |