The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Biolox Delta Ceramic Femoral Head.
| Device ID | K071535 |
| 510k Number | K071535 |
| Device Name: | BIOLOX DELTA CERAMIC FEMORAL HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Patricia Jenks |
| Correspondent | Patricia Jenks ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-05 |
| Decision Date | 2007-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024276840 | K071535 | 000 |
| 00889024430419 | K071535 | 000 |
| 00889024430402 | K071535 | 000 |
| 00889024430396 | K071535 | 000 |
| 00889024430389 | K071535 | 000 |
| 00889024430372 | K071535 | 000 |
| 00889024430365 | K071535 | 000 |
| 00889024430358 | K071535 | 000 |
| 00889024430341 | K071535 | 000 |
| 00889024430334 | K071535 | 000 |
| 00889024430327 | K071535 | 000 |
| 00889024430310 | K071535 | 000 |
| 00889024430303 | K071535 | 000 |
| 00889024430297 | K071535 | 000 |
| 00889024430426 | K071535 | 000 |
| H84400877502801 | K071535 | 000 |
| 00889024276833 | K071535 | 000 |
| 00889024276826 | K071535 | 000 |
| 00889024276819 | K071535 | 000 |
| 00889024276802 | K071535 | 000 |
| 00889024276796 | K071535 | 000 |
| 00889024276789 | K071535 | 000 |
| 00889024276772 | K071535 | 000 |
| 00889024276765 | K071535 | 000 |
| 00889024276758 | K071535 | 000 |
| 00889024276741 | K071535 | 000 |
| 00889024276734 | K071535 | 000 |
| 00889024276727 | K071535 | 000 |
| 00889024276710 | K071535 | 000 |
| 00889024430280 | K071535 | 000 |