The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Reflection Constrained Liner.
| Device ID | K033442 |
| 510k Number | K033442 |
| Device Name: | REFLECTION CONSTRAINED LINER |
| Classification | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Kanu Vadodaria |
| Correspondent | Kanu Vadodaria SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | KWZ |
| CFR Regulation Number | 888.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-29 |
| Decision Date | 2003-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010550064 | K033442 | 000 |
| 03596010510860 | K033442 | 000 |
| 03596010550057 | K033442 | 000 |
| 03596010510891 | K033442 | 000 |
| 03596010482648 | K033442 | 000 |
| 03596010510884 | K033442 | 000 |
| 03596010510877 | K033442 | 000 |