The following data is part of a premarket notification filed by Smith And Nephew Donjoy, Inc. with the FDA for Rounded Cannulated Inside-out (rci) Acl Screw.
| Device ID | K932862 |
| 510k Number | K932862 |
| Device Name: | ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | SMITH AND NEPHEW DONJOY, INC. 2777 LOKER AVENUE WEST Carsbad, CA 92008 -6601 |
| Contact | Dan Miller |
| Correspondent | Dan 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 For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-11 |
| Decision Date | 1994-03-10 |