The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Zirconium Alloy Frmoral Head.
| Device ID | K914878 |
| 510k Number | K914878 |
| Device Name: | ZIRCONIUM ALLOY FRMORAL HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Tom Craig |
| Correspondent | Tom 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 | 1991-10-30 |
| Decision Date | 1992-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010502285 | K914878 | 000 |
| 03596010502278 | K914878 | 000 |
| 03596010502261 | K914878 | 000 |
| 03596010502254 | K914878 | 000 |
| 03596010502247 | K914878 | 000 |
| 03596010502230 | K914878 | 000 |
| 03596010502032 | K914878 | 000 |
| 03596010502025 | K914878 | 000 |
| 03596010502018 | K914878 | 000 |