The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Mmf Screw.
| Device ID | K050535 |
| 510k Number | K050535 |
| Device Name: | STRYKER MMF SCREW |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Nathan M Miersma |
| Correspondent | Nathan M Miersma STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-02 |
| Decision Date | 2005-03-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327003970 | K050535 | 000 |
| 07613154716302 | K050535 | 000 |
| 07613154716289 | K050535 | 000 |
| 04546540732101 | K050535 | 000 |
| 34546540732027 | K050535 | 000 |
| 34546540732010 | K050535 | 000 |