Arx 13-10560-03

GUDID 00190837074807

Polyaxial Cannulated Screw 10.5x60mm

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837074807
NIH Device Record Key5f1983e9-a754-4323-a9e0-f1432986a0b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameArx
Version Model Number13-10560-03
Catalog Number13-10560-03
Company DUNS183641617
Company NameLife Spine, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100190837074807 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837074807]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-14
Device Publish Date2019-11-06

On-Brand Devices [Arx]

00190837075514Polyaxial Non-Cannulated Screw, 10.5x30mm
00190837075507Polyaxial Non-Cannulated Screw, 10.5x 25mm
00190837075453Polyaxial Non-Cannulated Screw, 10.5x55mm
00190837075446Polyaxial Non-Cannulated Screw, 10.5x50mm
00190837075439Polyaxial Non-Cannulated Screw, 10.5x45mm
00190837075422Polyaxial Non-Cannulated Screw, 10.5x40mm
00190837075415Polyaxial Non-Cannulated Screw, 10.5x35mm
00190837075200Polyaxial Cannulated Screw 10.5x120mm
00190837075194Polyaxial Cannulated Screw 10.5x110mm
00190837075057Polyaxial Cannulated Screw (Closed) 9.5x120mm
00190837075040Polyaxial Cannulated Screw (Closed) 9.5x110mm
00190837075033Polyaxial Cannulated Screw (Closed) 9.5x100mm
00190837075026Polyaxial Cannulated Screw (Closed) 9.5x90mm
00190837075019Polyaxial Cannulated Screw (Closed) 9.5x80mm
00190837075002Polyaxial Cannulated Screw (Closed) 9.5x70mm
00190837074999Polyaxial Cannulated Screw 9.5x60mm
00190837074968Polyaxial Cannulated Screw (Closed) 8.5x100mm
00190837074951Polyaxial Cannulated Screw (Closed) 8.5x80mm
00190837074920Polyaxial Cannulated Screw 8.5x60mm
00190837074845Polyaxial Cannulated Screw 10.5x100mm
00190837074838Polyaxial Cannulated Screw 10.5x90mm
00190837074821Polyaxial Cannulated Screw 10.5x80mm
00190837074814Polyaxial Cannulated Screw 10.5x70mm
00190837074807Polyaxial Cannulated Screw 10.5x60mm
00190837074265Closed Tulip Lock Screw
00190837074258Polyaxial Non-Cannulated Screw (Closed) 9.5x90mm
00190837074241Polyaxial Non-Cannulated Screw (Closed) 9.5x80mm
00190837074234Polyaxial Non-Cannulated Screw (Closed) 9.5x70mm
00190837074227Polyaxial Non-Cannulated Screw (Closed) 9.5x60mm
00190837074210Polyaxial Non-Cannulated Screw (Closed) 9.5x120mm
00190837074203Polyaxial Non-Cannulated Screw (Closed) 9.5x110mm
00190837074197Polyaxial Non-Cannulated Screw (Closed) 9.5x100mm
00190837074173Polyaxial Non-Cannulated Screw (Closed) 8.5x80mm
00190837074166Polyaxial Non-Cannulated Screw (Closed) 8.5x70mm
00190837074135Polyaxial Non-Cannulated Screw (Closed) 8.5x110mm
00190837074128Polyaxial Non-Cannulated Screw (Closed) 8.5x100mm
00190837074111Polyaxial Non-Cannulated Screw (Closed) 7.5x90mm
00190837073893Polyaxial Non-Cannulated Screw, 10.5x90mm
00190837073886Polyaxial Non-Cannulated Screw, 10.5x80mm
00190837073879Polyaxial Non-Cannulated Screw, 10.5x70mm
00190837073862Polyaxial Non-Cannulated Screw, 10.5x60mm
00190837073855Polyaxial Non-Cannulated Screw 10.5x120mm
00190837073848Polyaxial Non-Cannulated Screw 10.5x110mm
00190837073831Polyaxial Non-Cannulated Screw, 10.5x100mm
00190837036324Table Mount. Rod Cutter
00190837036317ARX Thoracolumbar Screw Assembly; 8.5mm x 55mm
00190837036300ARX Thoracolumbar Screw Assembly; 8.5mm x 50mm
00190837036294ARX Thoracolumbar Screw Assembly; 8.5mm x 45mm
00190837036287ARX Thoracolumbar Screw Assembly; 8.5mm x 40mm
00190837036270ARX Thoracolumbar Screw Assembly; 8.5mm x 35mm

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