The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Modular Hip System.
| Device ID | K912593 |
| 510k Number | K912593 |
| Device Name: | MODULAR HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Richard F Games |
| Correspondent | Richard F Games SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-10 |
| Decision Date | 1991-10-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010437600 | K912593 | 000 |
| 03596010436092 | K912593 | 000 |
| 03596010436085 | K912593 | 000 |
| 03596010435781 | K912593 | 000 |
| 03596010435774 | K912593 | 000 |
| 03596010435736 | K912593 | 000 |
| 03596010435446 | K912593 | 000 |
| 03596010434630 | K912593 | 000 |
| 03596010432674 | K912593 | 000 |
| 03596010437488 | K912593 | 000 |
| 03596010437495 | K912593 | 000 |
| 03596010437594 | K912593 | 000 |
| 03596010437587 | K912593 | 000 |
| 03596010437570 | K912593 | 000 |
| 03596010437563 | K912593 | 000 |
| 03596010437532 | K912593 | 000 |
| 03596010437525 | K912593 | 000 |
| 03596010437518 | K912593 | 000 |
| 03596010437501 | K912593 | 000 |
| 03596010427151 | K912593 | 000 |