510(k) K872949

ACROMED BONE PLATE BENDER by Buckman Co., Inc. — Product Code HXW

K872949 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "ACROMED BONE PLATE BENDER". The FDA issued a decision of Substantially Equivalent on October 15, 1987. The device falls under product code HXW (Bender), 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
October 15, 1987
Date Received
July 28, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bender
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type