The following data is part of a premarket notification filed by Osteomed L.p. with the FDA for Primalok Facet Fixation System.
| Device ID | K102438 |
| 510k Number | K102438 |
| Device Name: | PRIMALOK FACET FIXATION SYSTEM |
| Classification | System, Facet Screw Spinal Device |
| Applicant | OSTEOMED L.P. 8202 SHERMAN ROAD Chesterland, OH 44026 |
| Contact | Karen E Warden |
| Correspondent | Karen E Warden OSTEOMED L.P. 8202 SHERMAN ROAD Chesterland, OH 44026 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-26 |
| Decision Date | 2010-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813210022034 | K102438 | 000 |
| 00813210022027 | K102438 | 000 |
| 00813210022010 | K102438 | 000 |
| 00813210022003 | K102438 | 000 |
| 00813210021990 | K102438 | 000 |
| 00813210021983 | K102438 | 000 |
| 00813210021976 | K102438 | 000 |
| 00813210021969 | K102438 | 000 |
| 00813210021952 | K102438 | 000 |