The following data is part of a premarket notification filed by Biocomposites Ltd. with the FDA for Modification To Doubleplay Suture Anchor.
| Device ID | K081428 |
| 510k Number | K081428 |
| Device Name: | MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR |
| Classification | Screw, Fixation, Bone |
| Applicant | BIOCOMPOSITES LTD. KEELE SCIENCE PARK Keele, Staffordshire, GB St5 5nl |
| Contact | Simon Fitzer |
| Correspondent | Simon Fitzer BIOCOMPOSITES LTD. KEELE SCIENCE PARK Keele, Staffordshire, GB St5 5nl |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-21 |
| Decision Date | 2008-06-20 |