The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Mdf Revision Hip System.
| Device ID | K081124 |
| 510k Number | K081124 |
| Device Name: | MDF REVISION HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Rishi Sinha |
| Correspondent | Rishi Sinha SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-21 |
| Decision Date | 2008-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556025949 | K081124 | 000 |
| 00885556022597 | K081124 | 000 |
| 00885556022573 | K081124 | 000 |
| 00885556022412 | K081124 | 000 |
| 00885556022382 | K081124 | 000 |
| 03596010619556 | K081124 | 000 |
| 03596010620668 | K081124 | 000 |
| 03596010620651 | K081124 | 000 |
| 03596010620644 | K081124 | 000 |
| 03596010620637 | K081124 | 000 |
| 03596010620620 | K081124 | 000 |
| 03596010620613 | K081124 | 000 |
| 03596010620606 | K081124 | 000 |
| 00885556022733 | K081124 | 000 |
| 00885556023075 | K081124 | 000 |
| 00885556024713 | K081124 | 000 |
| 00885556024478 | K081124 | 000 |
| 00885556023969 | K081124 | 000 |
| 00885556023891 | K081124 | 000 |
| 00885556023785 | K081124 | 000 |
| 00885556023778 | K081124 | 000 |
| 00885556023518 | K081124 | 000 |
| 00885556023464 | K081124 | 000 |
| 00885556023433 | K081124 | 000 |
| 00885556023280 | K081124 | 000 |
| 00885556023136 | K081124 | 000 |
| 00885556023099 | K081124 | 000 |
| 03596010620590 | K081124 | 000 |