The following data is part of a premarket notification filed by Smith And Nephew Donjoy, Inc. with the FDA for Aims Cannulated Acl Screw (7mm Diameter).
| Device ID | K945236 |
| 510k Number | K945236 |
| Device Name: | AIMS CANNULATED ACL SCREW (7MM DIAMETER) |
| Classification | Screw, Fixation, Bone |
| Applicant | SMITH AND NEPHEW DONJOY, INC. 2777 LOKER AVENUE WEST Carsbad, CA 92008 -6601 |
| Contact | Dan W Miller |
| Correspondent | Dan W Miller SMITH AND NEPHEW DONJOY, INC. 2777 LOKER AVENUE WEST Carsbad, CA 92008 -6601 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-27 |
| Decision Date | 1995-02-03 |