The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for R3 Constrained Liner, Constrained Liner.
| Device ID | K083566 |
| 510k Number | K083566 |
| Device Name: | R3 CONSTRAINED LINER, CONSTRAINED LINER |
| Classification | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Jason Sells |
| Correspondent | Jason Sells SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | KWZ |
| CFR Regulation Number | 888.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-03 |
| Decision Date | 2009-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556022443 | K083566 | 000 |
| 00885556021668 | K083566 | 000 |
| 00885556021620 | K083566 | 000 |
| 00885556021330 | K083566 | 000 |
| 00885556020876 | K083566 | 000 |
| 00885556020852 | K083566 | 000 |
| 00885556020470 | K083566 | 000 |
| 00885556020227 | K083566 | 000 |