The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Rogozinski Spinal Rod System Screw.
| Device ID | K930298 |
| 510k Number | K930298 |
| Device Name: | ROGOZINSKI SPINAL ROD SYSTEM SCREW |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Les Sprinkle |
| Correspondent | Les Sprinkle SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-21 |
| Decision Date | 1995-06-14 |