510(k) K934044
K934044 is an FDA 510(k) premarket notification submitted by Smith And Nephew Donjoy, Inc. for the device "ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION SYSTEM". The FDA issued a decision of Substantially Equivalent on Mar 10, 1994. 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
- Mar 10, 1994
- Date Received
- Aug 19, 1993
- 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)