The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Titanium Classic Compression Hip Screw System.
| Device ID | K952697 |
| 510k Number | K952697 |
| Device Name: | TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116 |
| Contact | Marc A Wheetley |
| Correspondent | Marc A Wheetley SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-13 |
| Decision Date | 1995-09-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556015421 | K952697 | 000 |
| 03596010180476 | K952697 | 000 |
| 03596010180469 | K952697 | 000 |
| 03596010180452 | K952697 | 000 |
| 03596010180445 | K952697 | 000 |
| 03596010180438 | K952697 | 000 |
| 03596010180421 | K952697 | 000 |
| 03596010180414 | K952697 | 000 |
| 03596010180407 | K952697 | 000 |
| 03596010180483 | K952697 | 000 |
| 03596010180490 | K952697 | 000 |
| 03596010180506 | K952697 | 000 |
| 03596010457639 | K952697 | 000 |
| 03596010457622 | K952697 | 000 |
| 03596010457592 | K952697 | 000 |
| 03596010457585 | K952697 | 000 |
| 03596010457561 | K952697 | 000 |
| 03596010457530 | K952697 | 000 |
| 03596010180520 | K952697 | 000 |
| 03596010180513 | K952697 | 000 |
| 03596010180391 | K952697 | 000 |