The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Magna-fx And Mini Magna-fx Cannulated Screw Fixation System.
| Device ID | K142442 |
| 510k Number | K142442 |
| Device Name: | MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Patrick Mccullagh |
| Correspondent | Stephen H Mckelvey ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-02 |
| Decision Date | 2014-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024024809 | K142442 | 000 |
| 00889024024748 | K142442 | 000 |