The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Rj Constrained Liners.
| Device ID | K111635 |
| 510k Number | K111635 |
| Device Name: | SMITH & NEPHEW RJ CONSTRAINED LINERS |
| Classification | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Megan Bevill |
| Correspondent | Megan Bevill 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 | 2011-06-13 |
| Decision Date | 2011-09-09 |
| Summary: | summary |