The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Modular Acetabular Cup System.
| Device ID | K920430 |
| 510k Number | K920430 |
| Device Name: | MODULAR ACETABULAR CUP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Thomas L Craig |
| Correspondent | Thomas L Craig 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 | 1992-02-03 |
| Decision Date | 1992-07-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556043431 | K920430 | 000 |
| 03596010197658 | K920430 | 000 |
| 03596010197665 | K920430 | 000 |
| 03596010197672 | K920430 | 000 |
| 03596010197689 | K920430 | 000 |
| 03596010197696 | K920430 | 000 |
| 03596010197702 | K920430 | 000 |
| 03596010472373 | K920430 | 000 |
| 03596010000644 | K920430 | 000 |
| 00885556042434 | K920430 | 000 |
| 03596010197641 | K920430 | 000 |