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510(k) K112960

LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTURE by Cayenne Medical, Inc. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2012
Date Received
October 5, 2011
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

Other clearances by Cayenne Medical, Inc.

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  • K161033 — AFX™ Femoral Implant With Inserter (August 3, 2016)
  • K151068 — SureLock W Suture Anchor (July 24, 2015)
  • K143473 — Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needl (March 25, 2015)
  • K143392 — Quattro Bolt Tenodesis Screw (January 23, 2015)
  • K132867 — SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH (December 30, 2013)
  • K131325 — QUATTRO GL SUTURE ANCHOR (August 16, 2013)
  • K122314 — QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY (October 31, 2012)

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