The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Rogozinski Spinal Rod System Rod-to-bolt (universal) Connector For Use With The Simmons Plating System Bolt.
| Device ID | K950865 |
| 510k Number | K950865 |
| Device Name: | ROGOZINSKI SPINAL ROD SYSTEM ROD-TO-BOLT (UNIVERSAL) CONNECTOR FOR USE WITH THE SIMMONS PLATING SYSTEM BOLT |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116 |
| Contact | Jeff Cobb |
| Correspondent | Jeff Cobb SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-27 |
| Decision Date | 1995-09-01 |