Cayenne Medical Inc.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
23
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2571-2018Class IIDrill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mmOctober 10, 2013
Z-2422-2018Class IIAperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orJuly 11, 2013
Z-2548-2018Class IIAperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal CoriApril 28, 2010

Recent 510(k) Clearances

K-NumberDeviceDate
K192428AFX Femoral Implant with InserterOctober 5, 2019
K180274Ventix Link Knotless Anchor with InserterMarch 21, 2018
K172186BioWick X Implant with DriverOctober 16, 2017
K161033AFX™ Femoral Implant With InserterAugust 3, 2016
K151068SureLock W Suture AnchorJuly 24, 2015
K143473Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock AMarch 25, 2015
K143392Quattro Bolt Tenodesis ScrewJanuary 23, 2015
K132867SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MMDecember 30, 2013
K131325QUATTRO GL SUTURE ANCHORAugust 16, 2013
K122314QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLYOctober 31, 2012
K122463APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFOctober 11, 2012
K121413CROSSFIX II MEMISCAL REPAIR DEVICEJune 4, 2012
K112814CUFFINKJanuary 17, 2012
K112960LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTUREJanuary 9, 2012
K112876CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHORDecember 15, 2011
K083612APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MMMarch 4, 2009
K083607APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MMMarch 4, 2009
K082518DUAL NEEDLE SUTURE PASSER SYSTEMJanuary 16, 2009
K073426APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MMFebruary 19, 2008
K073054MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTERNovember 27, 2007