510(k) K143473

Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles by Cayenne Medical, Inc. — Product Code MBI

K143473 is an FDA 510(k) premarket notification submitted by Cayenne Medical, Inc. for the device "Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles". The FDA issued a decision of Substantially Equivalent on March 25, 2015. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Cayenne Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2015
Date Received
December 5, 2014
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