The following data is part of a premarket notification filed by Reliance Medical Systems, Llc with the FDA for Reliance Posterior Cervical- Thoracic System.
| Device ID | K122292 |
| 510k Number | K122292 |
| Device Name: | RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | Reliance Medical Systems, LLC 545 WEST 500 SOUTH SUITE 100 Bountiful, UT 84010 |
| Contact | Bret M Berry |
| Correspondent | Bret M Berry Reliance Medical Systems, LLC 545 WEST 500 SOUTH SUITE 100 Bountiful, UT 84010 |
| Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-31 |
| Decision Date | 2012-10-24 |
| Summary: | summary |