The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Reflection Constrained Liner.
| Device ID | K021803 |
| 510k Number | K021803 |
| 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 | Janet Johnson Green |
| Correspondent | Janet Johnson Green SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | KWZ |
| CFR Regulation Number | 888.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-03 |
| Decision Date | 2002-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010480118 | K021803 | 000 |
| 03596010480064 | K021803 | 000 |
| 03596010480071 | K021803 | 000 |
| 03596010480088 | K021803 | 000 |
| 03596010480125 | K021803 | 000 |
| 03596010480132 | K021803 | 000 |
| 03596010480149 | K021803 | 000 |
| 03596010480095 | K021803 | 000 |
| 03596010480101 | K021803 | 000 |
| 03596010480057 | K021803 | 000 |