ClearanceBrief
510(k) K113014 ยท HRS Plate, Fixation, Bone

CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS

ApplicantWrightmedicaltechnologyinc, Arlington TN, US
DecisionSubstantially Equivalent, Jan 31, 2012
ReceivedOct 11, 2011
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K113014

DateFirm and productCodeLinked 510(k)
Feb 24, 2023Wright Medical Technology, Inc.
ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device
Open, Classified		 HRSNone listed
Feb 24, 2023Wright Medical Technology, Inc.
ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device
Open, Classified		 HRSNone listed
Dec 3, 2021Wright Medical Technology Inc
Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430.
Open, Classified		 HRSNone listed
Sep 8, 2014Wright Medical Technology, Inc.
CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM, REF 40S20020, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Terminated		 HRSNone listed
Sep 8, 2014Wright Medical Technology, Inc.
CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH 3.5mm CLAW SCREW, REF 4013-0130, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Terminated		 HRSNone listed
Sep 8, 2014Wright Medical Technology, Inc.
CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Terminated		 HRSNone listed
Sep 8, 2014Wright Medical Technology, Inc.
CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Terminated		 HRSNone listed
Sep 8, 2014Wright Medical Technology, Inc.
CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 25mm, REF 40240225, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Terminated		 HRSNone listed
Sep 8, 2014Wright Medical Technology, Inc.
CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Terminated		 HRSNone listed
Sep 8, 2014Wright Medical Technology, Inc.
CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 20mm, REF 40242020, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Terminated		 HRSNone listed
Sep 8, 2014Wright Medical Technology, Inc.
CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm, REF 40242025, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Terminated		 HRSNone listed
Sep 8, 2014Wright Medical Technology, Inc.
CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 25mm x 25mm, REF 40242525, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Terminated		 HRSNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.