The following data is part of a premarket notification filed by Smith & Nephew, Inc., Orthopaedic Div. with the FDA for Titanium Spinal Rod System.
| Device ID | K970635 |
| 510k Number | K970635 |
| Device Name: | TITANIUM SPINAL ROD SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. 1450 EAST BROOKS RD. Memphis, TN 38116 |
| Contact | Joann Kuhne |
| Correspondent | Joann Kuhne SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. 1450 EAST BROOKS RD. Memphis, TN 38116 |
| Product Code | KWQ |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-20 |
| Decision Date | 1997-08-14 |
| Summary: | summary |