The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Intramedullary Hip Screw, Modification.
| Device ID | K912162 |
| 510k Number | K912162 |
| Device Name: | INTRAMEDULLARY HIP SCREW, MODIFICATION |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Robert F Games |
| Correspondent | Robert F Games SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-16 |
| Decision Date | 1991-08-14 |