The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Neer Iii Total Shoulder System.
| Device ID | K994350 |
| 510k Number | K994350 |
| Device Name: | NEER III TOTAL SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Neal Defibaugh |
| Correspondent | Neal Defibaugh SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-23 |
| Decision Date | 2000-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010480248 | K994350 | 000 |
| 03596010403353 | K994350 | 000 |
| 03596010403360 | K994350 | 000 |
| 03596010403377 | K994350 | 000 |
| 03596010403384 | K994350 | 000 |
| 03596010403391 | K994350 | 000 |
| 03596010403407 | K994350 | 000 |
| 03596010403414 | K994350 | 000 |
| 03596010403421 | K994350 | 000 |
| 03596010403438 | K994350 | 000 |
| 03596010403445 | K994350 | 000 |
| 03596010403452 | K994350 | 000 |
| 03596010466037 | K994350 | 000 |
| 03596010466044 | K994350 | 000 |
| 03596010466051 | K994350 | 000 |
| 03596010480200 | K994350 | 000 |
| 03596010403346 | K994350 | 000 |