The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Zirconium Alloy Uni-polar Head.
| Device ID | K934353 |
| 510k Number | K934353 |
| Device Name: | ZIRCONIUM ALLOY UNI-POLAR HEAD |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| 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 | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-08 |
| Decision Date | 1994-04-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010534774 | K934353 | 000 |
| 03596010534637 | K934353 | 000 |
| 03596010534644 | K934353 | 000 |
| 03596010534651 | K934353 | 000 |
| 03596010534668 | K934353 | 000 |
| 03596010534675 | K934353 | 000 |
| 03596010534682 | K934353 | 000 |
| 03596010534699 | K934353 | 000 |
| 03596010534705 | K934353 | 000 |
| 03596010534712 | K934353 | 000 |
| 03596010534729 | K934353 | 000 |
| 03596010534736 | K934353 | 000 |
| 03596010534743 | K934353 | 000 |
| 03596010534750 | K934353 | 000 |
| 03596010534767 | K934353 | 000 |
| 03596010534620 | K934353 | 000 |