510(k) K100414

PROTOE ENDOSORB SMALL HAMMER TOE PIN by Merete Medical GmbH — Product Code JDW

K100414 is an FDA 510(k) premarket notification submitted by Merete Medical GmbH for the device "PROTOE ENDOSORB SMALL HAMMER TOE PIN". The FDA issued a decision of Substantially Equivalent on July 2, 2010. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040. Merete Medical GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2010
Date Received
February 16, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Threaded
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type