The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Empower Anterior Direct Screws.
| Device ID | K965224 |
| 510k Number | K965224 |
| Device Name: | EMPOWER ANTERIOR DIRECT SCREWS |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116 |
| Contact | Thomas L Craig |
| Correspondent | Thomas L Craig SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-30 |
| Decision Date | 1997-05-08 |
| Summary: | summary |