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Panels › Orthopedic › Product code OWI · Class 2

Bone Fixation Cerclage, Sublaminar

Regulation 888.3010

2510(k)s in 12 months (37 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
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Top companies in OWI

Company510(k)sRecalls
Implanet, S.A.70
Medicrea International51
Globus Medical, Inc.30
K2m, Inc.30
OrthoPediatrics Corp.21
Cousin Biotech Sas20
Nu Vasive, Incorporated20
Spinal Elements, Inc.20
Zimmer Spine20
Alphatec Spine, Inc.10
DateFirm and productCodeLinked 510(k)
Oct 8, 2020Medicrea International
MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200
Terminated		 OWINone listed
Apr 24, 2017OrthoPediatrics Corp
Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommended tension to the band and hold it in place during spine m
Terminated		 OWIK161267

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