510(k) K860018

FISCHER WIRE/PIN CLAMP by Buckman Co., Inc. — Product Code HXK

K860018 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "FISCHER WIRE/PIN CLAMP". The FDA issued a decision of Substantially Equivalent on February 7, 1986. The device falls under product code HXK (Holder, Needle; Orthopedic), a Class I device regulated under 21 CFR 888.4540. Buckman Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1986
Date Received
January 3, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Needle; Orthopedic
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type