The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Biolox Delta Ceramic Femoral Heads.
| Device ID | K130899 |
| 510k Number | K130899 |
| Device Name: | BIOLOX DELTA CERAMIC FEMORAL HEADS |
| 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 | Rebecca M Brooks |
| Correspondent | Rebecca M Brooks ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-01 |
| Decision Date | 2013-05-01 |
| Summary: | summary |