The following data is part of a premarket notification filed by Biocomposites Ltd. with the FDA for Biolok Screw, Biosteon Screw.
| Device ID | K003641 |
| 510k Number | K003641 |
| Device Name: | BIOLOK SCREW, BIOSTEON SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | BIOCOMPOSITES LTD. ETRUSCAN ST., ETRURIA Stoke On Trent, GB St1 5pq |
| Contact | J.stephen Bratt |
| Correspondent | J.stephen Bratt BIOCOMPOSITES LTD. ETRUSCAN ST., ETRURIA Stoke On Trent, GB St1 5pq |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-27 |
| Decision Date | 2001-02-08 |
| Summary: | summary |