510(k) K951656

NEXMED CANCELLOUS BONE SCREWS by Nexmed, Inc. — Product Code HWC

K951656 is an FDA 510(k) premarket notification submitted by Nexmed, Inc. for the device "NEXMED CANCELLOUS BONE SCREWS". The FDA issued a decision of SN on July 18, 1995. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Nexmed, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
July 18, 1995
Date Received
April 10, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type