The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;.
| Device ID | K092331 |
| 510k Number | K092331 |
| Device Name: | DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110; |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Teffany Hutto |
| Correspondent | Teffany Hutto ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | KWA |
| Subsequent Product Code | KWZ |
| 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 | 2009-08-04 |
| Decision Date | 2010-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912081597 | K092331 | 000 |
| 00888912081269 | K092331 | 000 |
| 00888912081245 | K092331 | 000 |
| 00888912081221 | K092331 | 000 |
| 00888912081207 | K092331 | 000 |
| 00888912023757 | K092331 | 000 |
| 00888912023740 | K092331 | 000 |
| 00888912023733 | K092331 | 000 |
| 00888912023726 | K092331 | 000 |
| 00888912023719 | K092331 | 000 |
| 00888912023702 | K092331 | 000 |
| 00888912023696 | K092331 | 000 |
| 00888912081283 | K092331 | 000 |
| 00888912081306 | K092331 | 000 |
| 00888912081573 | K092331 | 000 |
| 00888912081535 | K092331 | 000 |
| 00888912081504 | K092331 | 000 |
| 00888912081481 | K092331 | 000 |
| 00888912081467 | K092331 | 000 |
| 00888912081443 | K092331 | 000 |
| 00888912081436 | K092331 | 000 |
| 00888912081412 | K092331 | 000 |
| 00888912081399 | K092331 | 000 |
| 00888912081375 | K092331 | 000 |
| 00888912081320 | K092331 | 000 |
| 00888912023689 | K092331 | 000 |