The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Modular Neer 3 Humeral Stems And Modular Neer 3 Humeral Heads.
| Device ID | K030344 |
| 510k Number | K030344 |
| Device Name: | MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | David Henley |
| Correspondent | David Henley SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-03 |
| Decision Date | 2003-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010483355 | K030344 | 000 |
| 03596010465832 | K030344 | 000 |
| 03596010465849 | K030344 | 000 |
| 03596010465856 | K030344 | 000 |
| 03596010465863 | K030344 | 000 |
| 03596010465870 | K030344 | 000 |
| 03596010478528 | K030344 | 000 |
| 03596010478535 | K030344 | 000 |
| 03596010478542 | K030344 | 000 |
| 03596010478566 | K030344 | 000 |
| 03596010480316 | K030344 | 000 |
| 03596010480323 | K030344 | 000 |
| 03596010465825 | K030344 | 000 |