The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Hip Computer Assisted Solutions Electromagnetic And Imageless Instrumentation.
| Device ID | K062228 |
| 510k Number | K062228 |
| Device Name: | ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGELESS INSTRUMENTATION |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Patricia Jenks |
| Correspondent | Patricia Jenks 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 | 2006-08-02 |
| Decision Date | 2006-11-08 |
| Summary: | summary |