The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith And Nephew Reflection 3 Acetabular System.
| Device ID | K070756 |
| 510k Number | K070756 |
| Device Name: | SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Nicholas Tabrizi |
| Correspondent | Nicholas Tabrizi SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | MBL |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-20 |
| Decision Date | 2007-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556187814 | K070756 | 000 |
| 03596010197634 | K070756 | 000 |
| 03596010597533 | K070756 | 000 |
| 03596010597540 | K070756 | 000 |
| 03596010597557 | K070756 | 000 |
| 03596010597564 | K070756 | 000 |
| 03596010598189 | K070756 | 000 |
| 03596010598196 | K070756 | 000 |
| 03596010598202 | K070756 | 000 |
| 03596010598219 | K070756 | 000 |
| 03596010607010 | K070756 | 000 |
| 00885556085387 | K070756 | 000 |
| 00885556085431 | K070756 | 000 |
| 00885556187760 | K070756 | 000 |
| 03596010597663 | K070756 | 000 |