510(k) K935646
K935646 is an FDA 510(k) premarket notification submitted by Biodynamic Technologies, Inc. for the device "FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM". The FDA issued a decision of SN on March 9, 1994. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. Biodynamic Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- March 9, 1994
- Date Received
- November 23, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cerclage, Fixation
- Device Class
- Class II
- Regulation Number
- 888.3010
- Review Panel
- OR
- Submission Type