510(k) K926579

TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE by Techmedica, Inc. — Product Code HWC

K926579 is an FDA 510(k) premarket notification submitted by Techmedica, Inc. for the device "TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE". The FDA issued a decision of Substantially Equivalent on April 6, 1993. 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
April 6, 1993
Date Received
November 24, 1992
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