510(k) K915187

CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW by Techmedica, Inc. — Product Code HWC

K915187 is an FDA 510(k) premarket notification submitted by Techmedica, Inc. for the device "CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW". The FDA issued a decision of Substantially Equivalent on December 19, 1991. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Techmedica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1991
Date Received
November 18, 1991
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