510(k) K935950

FX-CABLELOK CABLE/PLATE SYSTEM by Buckman Co., Inc. — Product Code JDQ

K935950 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "FX-CABLELOK CABLE/PLATE 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. Buckman Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
March 9, 1994
Date Received
December 13, 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