510(k) K875054

ACROMED ADS BONE NAIL DRIVER by Buckman Co., Inc. — Product Code HWR

K875054 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "ACROMED ADS BONE NAIL DRIVER". The FDA issued a decision of Substantially Equivalent on January 28, 1988. The device falls under product code HWR (Driver, Prosthesis), 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
January 28, 1988
Date Received
December 9, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Driver, Prosthesis
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type