The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Focus Total Hip System.
| Device ID | K883460 |
| 510k Number | K883460 |
| Device Name: | FOCUS TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Barry R Sisson |
| Correspondent | Barry R Sisson DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-15 |
| Decision Date | 1988-10-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295033219 | K883460 | 000 |
| 10603295033202 | K883460 | 000 |
| 10603295033134 | K883460 | 000 |
| 10603295033127 | K883460 | 000 |
| 10603295001317 | K883460 | 000 |
| 10603295001300 | K883460 | 000 |
| 10603295001249 | K883460 | 000 |
| 10603295001232 | K883460 | 000 |