510(k) K873067

ACROMED BONE SCREW TAP SLEEVES by Buckman Co., Inc. — Product Code HWX

K873067 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "ACROMED BONE SCREW TAP SLEEVES". The FDA issued a decision of Substantially Equivalent on September 2, 1987. The device falls under product code HWX (Tap, Bone), 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
September 2, 1987
Date Received
August 5, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tap, Bone
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type