The following data is part of a premarket notification filed by Smith & Nephew, Inc., Orthopaedic Div. with the FDA for Ultium Spinal Plating System.
| Device ID | K962784 |
| 510k Number | K962784 |
| Device Name: | ULTIUM SPINAL PLATING SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. 1450 E. BROOKS RD. Memphis, TN 38116 |
| Contact | Thomas L Craig |
| Correspondent | Thomas L Craig SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. 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 | 1996-07-17 |
| Decision Date | 1996-10-02 |
| Summary: | summary |