510(k) K945236
K945236 is an FDA 510(k) premarket notification submitted by Smith And Nephew Donjoy, Inc. for the device "AIMS CANNULATED ACL SCREW (7MM DIAMETER)". The FDA issued a decision of Substantially Equivalent on Feb 3, 1995. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Smith And Nephew Donjoy, Inc. has 14 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 3, 1995
- Date Received
- Oct 27, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Screw, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
- 510(k)