The following data is part of a premarket notification filed by Lima Intl. Corp. with the FDA for Lima Ceramic Femoral Head Biolox By Feldmuehle.
| Device ID | K896850 |
| 510k Number | K896850 |
| Device Name: | LIMA CERAMIC FEMORAL HEAD BIOLOX BY FELDMUEHLE |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | LIMA INTL. CORP. 392 WAMPANOAG TRAIL E Providence, RI 02915 |
| Contact | Pollonio-lister |
| Correspondent | Pollonio-lister LIMA INTL. CORP. 392 WAMPANOAG TRAIL E Providence, RI 02915 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-05 |
| Decision Date | 1990-06-05 |