The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Biolox Option Ceramic Femoral Head System, Model 8777 Series.
| Device ID | K073567 |
| 510k Number | K073567 |
| Device Name: | BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Patricia Jenks |
| Correspondent | Patricia Jenks ZIMMER GMBH 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 | 2007-12-20 |
| Decision Date | 2008-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024277007 | K073567 | 000 |
| 00889024430570 | K073567 | 000 |
| 00889024430563 | K073567 | 000 |
| 00889024430556 | K073567 | 000 |
| 00889024430549 | K073567 | 000 |
| 00889024430532 | K073567 | 000 |
| 00889024430525 | K073567 | 000 |
| 00889024430518 | K073567 | 000 |
| 00889024430501 | K073567 | 000 |
| 00889024430495 | K073567 | 000 |
| 00889024430488 | K073567 | 000 |
| 00889024430471 | K073567 | 000 |
| 00889024430464 | K073567 | 000 |
| 00889024430457 | K073567 | 000 |
| 00889024430440 | K073567 | 000 |
| 00889024430587 | K073567 | 000 |
| 00889024276857 | K073567 | 000 |
| 00889024276994 | K073567 | 000 |
| 00889024276987 | K073567 | 000 |
| 00889024276970 | K073567 | 000 |
| 00889024276963 | K073567 | 000 |
| 00889024276956 | K073567 | 000 |
| 00889024276949 | K073567 | 000 |
| 00889024276932 | K073567 | 000 |
| 00889024276925 | K073567 | 000 |
| 00889024276918 | K073567 | 000 |
| 00889024276901 | K073567 | 000 |
| 00889024276895 | K073567 | 000 |
| 00889024276888 | K073567 | 000 |
| 00889024276871 | K073567 | 000 |
| 00889024276864 | K073567 | 000 |
| 00889024430433 | K073567 | 000 |