The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Hip Joint Prothesis.
| Device ID | K921400 |
| 510k Number | K921400 |
| Device Name: | HIP JOINT PROTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| 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 | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-24 |
| Decision Date | 1993-04-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556024669 | K921400 | 000 |
| 03596010197917 | K921400 | 000 |
| 03596010197900 | K921400 | 000 |
| 03596010197887 | K921400 | 000 |
| 03596010197870 | K921400 | 000 |
| 03596010197863 | K921400 | 000 |
| 03596010197856 | K921400 | 000 |
| 03596010197818 | K921400 | 000 |
| 03596010197801 | K921400 | 000 |
| 03596010197795 | K921400 | 000 |
| 03596010197788 | K921400 | 000 |
| 03596010197771 | K921400 | 000 |
| 03596010007384 | K921400 | 000 |
| 03596010197924 | K921400 | 000 |
| 03596010197931 | K921400 | 000 |
| 00885556024003 | K921400 | 000 |
| 00885556022122 | K921400 | 000 |
| 00885556022054 | K921400 | 000 |
| 00885556021958 | K921400 | 000 |
| 00885556021903 | K921400 | 000 |
| 00885556021880 | K921400 | 000 |
| 00885556020906 | K921400 | 000 |
| 00885556020340 | K921400 | 000 |
| 03596010197986 | K921400 | 000 |
| 03596010197979 | K921400 | 000 |
| 03596010197962 | K921400 | 000 |
| 03596010197955 | K921400 | 000 |
| 03596010001788 | K921400 | 000 |