The following data is part of a premarket notification filed by Osteomed L.p. with the FDA for Primal Ok Interspinous Fusion System.
| Device ID | K100354 |
| 510k Number | K100354 |
| Device Name: | PRIMAL OK INTERSPINOUS FUSION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | OSTEOMED L.P. 8202 SHERMAN RD Chesterland, OH 44026 -2141 |
| Contact | Karen E Warden |
| Correspondent | Karen E Warden OSTEOMED L.P. 8202 SHERMAN RD Chesterland, OH 44026 -2141 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-12 |
| Decision Date | 2010-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813210022300 | K100354 | 000 |
| 00813210021365 | K100354 | 000 |
| 00813210021723 | K100354 | 000 |
| 00813210021730 | K100354 | 000 |
| 00813210021747 | K100354 | 000 |
| 00813210021754 | K100354 | 000 |
| 00813210021761 | K100354 | 000 |
| 00813210021778 | K100354 | 000 |
| 00813210021785 | K100354 | 000 |
| 00813210022249 | K100354 | 000 |
| 00813210022256 | K100354 | 000 |
| 00813210022263 | K100354 | 000 |
| 00813210022270 | K100354 | 000 |
| 00813210022287 | K100354 | 000 |
| 00813210022294 | K100354 | 000 |
| 00813210021358 | K100354 | 000 |