The following data is part of a premarket notification filed by Spinal Usa with the FDA for Sure Lok Mini Posterior Cervical/upper Thoracic System.
| Device ID | K112025 |
| 510k Number | K112025 |
| Device Name: | SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SPINAL USA 2050 EXECUTIVE DR. Pearl, MS 39208 |
| Contact | Frankie Cummins |
| Correspondent | Frankie Cummins SPINAL USA 2050 EXECUTIVE DR. Pearl, MS 39208 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-15 |
| Decision Date | 2011-09-15 |
| Summary: | summary |