The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Echelon Titanium Hip System.
| Device ID | K072817 |
| 510k Number | K072817 |
| Device Name: | ECHELON TITANIUM HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Marlon D Ridley |
| Correspondent | Marlon D Ridley SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | LPH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | JDJ |
| Subsequent Product Code | MBL |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-02 |
| Decision Date | 2008-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556112762 | K072817 | 000 |
| 00885556008904 | K072817 | 000 |
| 00885556008775 | K072817 | 000 |
| 00885556008720 | K072817 | 000 |
| 00885556008461 | K072817 | 000 |
| 00885556003633 | K072817 | 000 |
| 00885556003626 | K072817 | 000 |
| 00885556003619 | K072817 | 000 |
| 00885556003602 | K072817 | 000 |
| 00885556003596 | K072817 | 000 |
| 00885556003589 | K072817 | 000 |
| 00885556003572 | K072817 | 000 |
| 00885556003565 | K072817 | 000 |
| 00885556008966 | K072817 | 000 |
| 00885556009017 | K072817 | 000 |
| 00885556112755 | K072817 | 000 |
| 00885556022061 | K072817 | 000 |
| 00885556021767 | K072817 | 000 |
| 00885556021712 | K072817 | 000 |
| 00885556021682 | K072817 | 000 |
| 00885556021521 | K072817 | 000 |
| 00885556021385 | K072817 | 000 |
| 00885556020708 | K072817 | 000 |
| 00885556020586 | K072817 | 000 |
| 00885556020548 | K072817 | 000 |
| 00885556020197 | K072817 | 000 |
| 00885556020166 | K072817 | 000 |
| 00885556003558 | K072817 | 000 |