The following data is part of a premarket notification filed by Allo Pro Corp. with the FDA for Biolox Ceramic Ball.
| Device ID | K892644 |
| 510k Number | K892644 |
| Device Name: | BIOLOX CERAMIC BALL |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | ALLO PRO CORP. POST OFFICE BOX 14159 Clearwater, FL 34279 |
| Contact | Sylvia K Pierpoint |
| Correspondent | Sylvia K Pierpoint ALLO PRO CORP. POST OFFICE BOX 14159 Clearwater, FL 34279 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-12 |
| Decision Date | 1989-10-19 |