The following data is part of a premarket notification filed by Encore Medical Corporation with the FDA for Encore Clp Offset Total Hip System.
| Device ID | K052320 |
| 510k Number | K052320 |
| Device Name: | ENCORE CLP OFFSET TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | ENCORE MEDICAL CORPORATION 11201 PEPPER ROAD Hunt Valley, MD 21031 |
| Contact | Sam Son |
| Correspondent | Sam Son ENCORE MEDICAL CORPORATION 11201 PEPPER ROAD Hunt Valley, MD 21031 |
| Product Code | KWA |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-25 |
| Decision Date | 2005-12-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912079723 | K052320 | 000 |
| 00888912079778 | K052320 | 000 |
| 00888912079761 | K052320 | 000 |
| 00888912079754 | K052320 | 000 |
| 00888912079747 | K052320 | 000 |
| 00888912079730 | K052320 | 000 |
| 00888912079464 | K052320 | 000 |
| 00888912079457 | K052320 | 000 |
| 00888912079440 | K052320 | 000 |
| 00888912079433 | K052320 | 000 |
| 00888912079426 | K052320 | 000 |
| 00888912079419 | K052320 | 000 |
| 00888912079402 | K052320 | 000 |
| 00888912079389 | K052320 | 000 |
| 00888912079372 | K052320 | 000 |
| 00888912079365 | K052320 | 000 |
| 00888912079358 | K052320 | 000 |
| 00888912079785 | K052320 | 000 |
| 00888912079792 | K052320 | 000 |
| 00888912079716 | K052320 | 000 |
| 00888912079709 | K052320 | 000 |
| 00888912079693 | K052320 | 000 |
| 00888912079686 | K052320 | 000 |
| 00888912079679 | K052320 | 000 |
| 00888912079662 | K052320 | 000 |
| 00888912079655 | K052320 | 000 |
| 00888912079648 | K052320 | 000 |
| 00888912079631 | K052320 | 000 |
| 00888912079624 | K052320 | 000 |
| 00888912079617 | K052320 | 000 |
| 00888912079846 | K052320 | 000 |
| 00888912079839 | K052320 | 000 |
| 00888912079822 | K052320 | 000 |
| 00888912079815 | K052320 | 000 |
| 00888912079808 | K052320 | 000 |
| 00888912079341 | K052320 | 000 |