Paradigm Spine L L C

FDA Filings

This page includes the latest FDA filings for Paradigm Spine L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3005725110
FEI Number3005725110
NamePARADIGM SPINE, LLC
Owner & OperatorRTI Surgical
Contact Address11621 Research Cir
Alachua FL 32615 US
Official Correspondent
  • Kerry Pearson
  • 1-386-4188888-4111
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address505 Park Avenue 14th Floor
New York, NY 10022 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Paradigm Spine, LLC
CoFix Implant 16 mm RQI000162020-03-27
Paradigm Spine, LLC
CoFix Implant 14 mm RQI000142020-03-27
Paradigm Spine, LLC
CoFix Implant 12 mm RQI000122020-03-27
Paradigm Spine, LLC
CoFix Implant 10 mm RQI000102020-03-27
Paradigm Spine, LLC
CoFix Implant 8 mm RQI000082020-03-27
Paradigm Spine, LLC
coflex-F LIS screw inserter 2020-03-12
Paradigm Spine, LLC
CoFix Sterilization Tray 2020-03-12
Paradigm Spine, LLC
DSS HP Polyaxial pedicle screw set, Ø5 x 45mm 2019-09-26
Paradigm Spine, LLC
coflex crimping pliers, long 2018-11-23
Paradigm Spine, LLC
coflex dual pliers 2018-11-12
Paradigm Spine, LLC
coflex mallet cap 2018-09-03
Paradigm Spine, LLC
coflex Mallet 2018-09-03
Paradigm Spine, LLC
DSS Pedicle Screw Set, Ø7.0 x 60mm 2018-09-03
Paradigm Spine, LLC
DSS Pedicle Screw Set, Ø6.0 x 60mm 2018-09-03
Paradigm Spine, LLC
DSS Pedicle Screw Set, Ø5.0 x 60mm 2018-09-03
Paradigm Spine, LLC
coflex extractor pliers 2018-07-30
Paradigm Spine, LLC
coflex freehand crimping pliers 2018-07-30
Paradigm Spine, LLC
coflex wing loosener 2018-07-30
Paradigm Spine, LLC
coflex trial cap 2018-07-30
Paradigm Spine, LLC
coflex trial slider with wings 2018-07-30
Paradigm Spine, LLC
coflex trial with guide and x-ray marker, 16mm 2018-07-30
Paradigm Spine, LLC
coflex trial with guide and x-ray marker, 14mm 2018-07-30
Paradigm Spine, LLC
coflex trial with guide and x-ray marker, 12mm 2018-07-30
Paradigm Spine, LLC
coflex trial with guide and x-ray marker, 10mm 2018-07-30
Paradigm Spine, LLC
coflex trial with guide and x-ray marker, 8mm 2018-07-30
Paradigm Spine, LLC
coflex single-use instruments 2018-07-16
Paradigm Spine, LLC
coflex Revision pliers 2018-07-06
Paradigm Spine, LLC
coflex Crimping pliers 2018-07-06
Paradigm Spine, LLC
coflex Trial with wings and window, Size 16 2018-07-06
Paradigm Spine, LLC
coflex Trial with wings and window, Size 14 2018-07-06
Paradigm Spine, LLC
coflex Trial with wings and window, Size 12 2018-07-06
Paradigm Spine, LLC
coflex Trial with wings and window, Size 10 2018-07-06
Paradigm Spine, LLC
coflex Trial with wings and window, Size 8 2018-07-06
Paradigm Spine, LLC
coflex Trial with lower wings 2018-07-06
Paradigm Spine, LLC
coflex Trial with upper wings 2018-07-06
Paradigm Spine, LLC
coflex Trial with wings, 16mm 2018-07-06
Paradigm Spine, LLC
coflex Trial with wings, 14mm 2018-07-06
Paradigm Spine, LLC
coflex Trial with wings, 12mm 2018-07-06
Paradigm Spine, LLC
coflex Trial with wings, 10mm 2018-07-06
Paradigm Spine, LLC
coflex Trial with wings, 8mm 2018-07-06
Paradigm Spine, LLC
coflex Trial, 16mm 2018-07-06
Paradigm Spine, LLC
coflex Trial, 14mm 2018-07-06
Paradigm Spine, LLC
coflex Trial, 12mm 2018-07-06
Paradigm Spine, LLC
coflex Trial, 10mm 2018-07-06
Paradigm Spine, LLC
coflex Trial, 8mm 2018-07-06
Paradigm Spine, LLC
coflex Interlaminar Technology, 16mm 2018-07-06
Paradigm Spine, LLC
coflex Interlaminar Technology, 14mm 2018-07-06
Paradigm Spine, LLC
coflex Interlaminar Technology, 12mm 2018-07-06
Paradigm Spine, LLC
coflex Interlaminar Technology, 10mm 2018-07-06
Paradigm Spine, LLC
coflex Interlaminar Technology, 8mm 2018-07-06
Paradigm Spine, LLC
coflex Interlaminar Technology, 16mm 2018-07-06
Paradigm Spine, LLC
coflex Interlaminar Technology, US, Size 14 2018-07-06
Paradigm Spine, LLC
coflex Interlaminar Technology, 12mm 2018-07-06
Paradigm Spine, LLC
coflex Interlaminar Technology, 10mm 2018-07-06
Paradigm Spine, LLC
coflex Interlaminar Technology, 8mm 2018-07-06
Paradigm Spine, LLC
coflex Sterilization tray 2018-07-06
Paradigm Spine, LLC
coflex-F trial with X-ray marker, Size 16 2018-07-06
Paradigm Spine, LLC
coflex-F trial with X-ray marker, Size 14 2018-07-06
Paradigm Spine, LLC
coflex-F trial with X-ray marker, Size 12 2018-07-06
Paradigm Spine, LLC
coflex-F trial with X-ray marker, Size 10 2018-07-06
Paradigm Spine, LLC
coflex-F trial with X-ray marker, Size 8 2018-07-06
Paradigm Spine, LLC
coflex-F Punching Pliers replacement inserts 2018-07-06
Paradigm Spine, LLC
coflex-F Punching Pliers 2018-07-06
Paradigm Spine, LLC
coflex-F Handle with ratchet 2018-07-06
Paradigm Spine, LLC
coflex-F Screwdriver 2018-07-06
Paradigm Spine, LLC
coflex-F Punching pliers with guiding 2018-07-06
Paradigm Spine, LLC
coflex-F Punching Pliers replacement inserts 2018-07-06
Paradigm Spine, LLC
coflex-F Screw inserter 2018-07-06
Paradigm Spine, LLC
coflex-F™ Cleaning tool 2018-07-06
Paradigm Spine, LLC
coflex-F Trial cap 2018-07-06
Paradigm Spine, LLC
coflex-F™ System 16mm 2018-07-06
Paradigm Spine, LLC
coflex-F™ System 14mm 2018-07-06
Paradigm Spine, LLC
coflex-F™ System 12mm 2018-07-06
Paradigm Spine, LLC
coflex-F™ System 10mm 2018-07-06
Paradigm Spine, LLC
coflex-F™ system, 8mm 2018-07-06
Paradigm Spine, LLC
coflex-F Wrench 2018-07-06
Paradigm Spine, LLC
coflex-F™ Screw Inserter 2018-07-06
Paradigm Spine, LLC
coflex-F Screwdriver 2018-07-06
Paradigm Spine, LLC
coflex-F Cleaning tool 2018-07-06
Paradigm Spine, LLC
coflex-F Probe 2018-07-06
Paradigm Spine, LLC
coflex-F Punching Pliers replacement inserts 2018-07-06
Paradigm Spine, LLC
coflex-F Punching Pliers 2018-07-06
Paradigm Spine, LLC
coflex-F™ Sterilization tray 2018-07-06
Paradigm Spine, LLC
coflex-F trial, 16mm 2018-07-06
Paradigm Spine, LLC
coflex-F trial, 14mm 2018-07-06
Paradigm Spine, LLC
coflex-F trial, 12mm 2018-07-06
Paradigm Spine, LLC
coflex-F trial, 10mm 2018-07-06
Paradigm Spine, LLC
coflex-F trial, 8mm 2018-07-06
Paradigm Spine, LLC
coflex Mallet cap 2018-07-06
Paradigm Spine, LLC
coflex Mallet 2018-07-06
Paradigm Spine, LLC
coflex Crimping pliers 2018-07-06
Paradigm Spine, LLC
coflex Bending pliers 2018-07-06
PARADIGM SPINE, LLC
Paradigm Spine Coflex Interlaminar Stabilization2018-06-21
Paradigm Spine, LLC
DSS Wire mesh tray, assembly 2018-05-08
Paradigm Spine, LLC
DSS sterilization tray 2018-05-08
PARADIGM SPINE, LLC
coflex® Interlaminar Technology2018-04-25
PARADIGM SPINE, LLC
COFLEX® INTERLAMINAR TECHNOLOGY2018-04-20
Paradigm Spine, LLC
DSS™ Coupler Length Adjuster 2018-03-29
Paradigm Spine, LLC
DSS™ Coupler Pusher 2018-03-29
Paradigm Spine, LLC
DSS™ Dynamic Coupler Inserter 2018-03-29
Paradigm Spine, LLC
DSS™ Tray for Nut, Spacer & Washer 2018-03-29
Paradigm Spine, LLC
DSS™ Spacer inserter 2018-03-29
Paradigm Spine, LLC
DSS™ Nut driver 2018-03-29
PARADIGM SPINE, LLC
COFLEX INTERLAMINAR TECHNOLOGY2017-03-10
PARADIGM SPINE, LLC
coflex® Interlaminar Technology2016-11-30
PARADIGM SPINE, LLC [RTI Surgical]
coflex-F+2016-10-16
PARADIGM SPINE, LLC [RTI Surgical]
CoFix2016-10-16
PARADIGM SPINE, LLC
Coflex-IF2016-09-08
PARADIGM SPINE, LLC [RTI Surgical]
coflex-F2016-09-01
PARADIGM SPINE, LLC
coflex Interlaminar Technology2016-02-09
PARADIGM SPINE, LLC
COFLEX® INTERLAMINAR TECHNOLOGY2013-04-23
PARADIGM SPINE, LLC
COFLEX® INTERLAMINAR TECHNOLOGY2013-04-23
PARADIGM SPINE, LLC [RTI Surgical]
coflex Interlaminar Technology2013-02-01
PARADIGM SPINE, LLC
COFLEX® INTERLAMINAR TECHNOLOGY2012-10-17
PARADIGM SPINE, LLC
DSS STABILIZATION SYSTEM-RIGID2012-05-09
PARADIGM SPINE, LLC
COFLEX-F2012-02-13
PARADIGM SPINE, LLC
DSS STABILIZATION SYSTEM2012-01-10
PARADIGM SPINE, LLC [RTI Surgical]
cofuse2010-10-15
PARADIGM SPINE, LLC [RTI Surgical]
coflex-f2010-10-15
PARADIGM SPINE, LLC [RTI Surgical]
PIFP2010-10-15
PARADIGM SPINE, LLC
PARADIGM INTERSPINOUS FUSION PLATE2010-10-06
PARADIGM SPINE, LLC [RTI Surgical]
DSS Stabilization System - Rigid2010-07-20
PARADIGM SPINE, LLC [RTI Surgical]
DSS Stabilization System - Rigid2010-07-20
PARADIGM SPINE, LLC [RTI Surgical]
DSS Stabilization System - Rigid2010-07-20
PARADIGM SPINE, LLC [RTI Surgical]
DSS Stabilization System - Rigid2010-07-20
PARADIGM SPINE LLC
DSS STABILIZATION SYSTEM2010-07-02
PARADIGM SPINE, LLC [RTI Surgical]
DSS2010-01-15
PARADIGM SPINE, LLC [RTI Surgical]
DSS2010-01-15
PARADIGM SPINE, LLC [RTI Surgical]
DSS2010-01-15
PARADIGM SPINE, LLC [RTI Surgical]
DSS2010-01-15
PARADIGM SPINE, LLC [RTI Surgical]
DSS2010-01-15
PARADIGM SPINE, LLC [RTI Surgical]
DSS2010-01-15
PARADIGM SPINE, LLC [RTI Surgical]
DSS2010-01-15
PARADIGM SPINE, LLC [RTI Surgical]
DSS2010-01-15
PARADIGM SPINE, LLC [RTI Surgical]
DSS2010-01-15
PARADIGM SPINE, LLC [RTI Surgical]
DSS2010-01-15
PARADIGM SPINE, LLC [RTI Surgical]
DSS2010-01-15
PARADIGM SPINE, LLC [RTI Surgical]
DSS2010-01-15
PARADIGM SPINE, LLC [RTI Surgical]
DSS2010-01-15
PARADIGM SPINE, LLC
MODIFICATION TO: DSS STABILIZATION SYSTEM2009-08-03
PARADIGM SPINE, LLC
DSS STABILIZATION SYSTEM2009-06-19
PARADIGM SPINE, LLC
MODIFICATION TO: DSS STABILIZATION SYSTEM2009-03-20
PARADIGM SPINE, LLC
DDS STABILIZATION SYSTEM2008-11-28
PARADIGM SPINE, LLC [RTI Surgical]
DSS2008-10-07
PARADIGM SPINE, LLC
DSS2008-01-24

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