510(k) K982169

SHERLOCK THREADED SUTURE ANCHOR (TIN COATED) by Doctor'S Research Group, Inc. — Product Code MBI

K982169 is an FDA 510(k) premarket notification submitted by Doctor'S Research Group, Inc. for the device "SHERLOCK THREADED SUTURE ANCHOR (TIN COATED)". The FDA issued a decision of Substantially Equivalent on September 14, 1998. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Doctor'S Research Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1998
Date Received
June 19, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type