510(k) K133835

ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM by Arthrosurface, Inc. — Product Code HTN

K133835 is an FDA 510(k) premarket notification submitted by Arthrosurface, Inc. for the device "ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM". The FDA issued a decision of Substantially Equivalent on July 3, 2014. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. Arthrosurface, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2014
Date Received
December 18, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Washer, Bolt Nut
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type