VELOX 4020-110

GUDID 00193082077357

VELOX ACP System, Implants and Instruments Case

SPINECRAFT, LLC

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit
Primary Device ID00193082077357
NIH Device Record Keyf175de08-200b-4ad9-88be-acaeb0db127e
Commercial Distribution StatusIn Commercial Distribution
Brand NameVELOX
Version Model Number4020-110
Catalog Number4020-110
Company DUNS783908713
Company NameSPINECRAFT, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100193082077357 [Primary]
GS100193082077357 [Primary]
GS100193082077357 [Primary]
GS100193082077357 [Primary]
GS100193082077357 [Primary]
GS100193082077357 [Primary]
GS100193082077357 [Primary]
GS100193082077357 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00193082077357]

Moist Heat or Steam Sterilization


[00193082077357]

Moist Heat or Steam Sterilization


[00193082077357]

Moist Heat or Steam Sterilization


[00193082077357]

Moist Heat or Steam Sterilization


[00193082077357]

Moist Heat or Steam Sterilization


[00193082077357]

Moist Heat or Steam Sterilization


[00193082077357]

Moist Heat or Steam Sterilization


[00193082077357]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

On-Brand Devices [VELOX]

00193082112454VELOX Screw Extractor Gen II
00193082077678Screw Pliers
00193082077661Caliper
00193082077654Plate Holder
00193082077647Quick Connect Handle
0019308207763018 mm Drill Bit
0019308207762316 mm Drill Bit
0019308207761614 mm Drill Bit
0019308207760912 mm Drill Bit
00193082077593Velox Awl
00193082077586Temporary Pin Inserter
00193082077579Temporary Pin
00193082077562Inserter Drill Guide Shaft
00193082077555Inserter Drill Guide, 7mm and 8mm ORIO Cage
00193082077548Inserter Drill Guide, 6mm cage Cage
00193082077531Inserter Drill Guide, 4mm and 5mm ORIO Cage
00193082077524Endplate Drill Guide
00193082077517VELOX Stripped Bone Screw Remover
00193082077500VELOX Plate Bender
00193082077470Variable Angle Drill Guide
00193082077463VELOX Screw Extractor
00193082077456VELOX Screw Remover
00193082077432VELOX Dia.4.5mm Screw Caddy
00193082077425VELOX Dia.4.0mm Screw Caddy
00193082121234VELOx Screwdriver, with Solid Pin, Short Length
00193082112652VELOx Screwdriver, with Solid Pin, Regular Length
00193082001154VELOX ACP Variable Angle Cervical Screw DIA.4.5mm 18mm
00193082001147VELOX ACP Variable Angle Cervical Screw DIA.4.5mm 16mm
00193082001130VELOX ACP Variable Angle Cervical Screw DIA.4.5mm 14mm
00193082001123VELOX ACP Variable Angle Cervical Screw DIA.4.5mm 12mm
00193082001116VELOX ACP Variable Angle Cervical Screw DIA.4mm 18mm
00193082001109VELOX ACP Variable Angle Cervical Screw DIA.4mm 16mm
00193082001093VELOX ACP Variable Angle Cervical Screw DIA.4mm 14mm
00193082001086VELOX ACP Variable Angle Cervical Screw DIA.4mm 12mm
00193082001079VELOX ACP Fixed Angle Cervical Screw DIA.4.5mm 18mm
00193082001062VELOX ACP Fixed Angle Cervical Screw DIA.4.5mm 16mm
00193082001055VELOX ACP Fixed Angle Cervical Screw DIA.4.5mm 14mm
00193082001048VELOX ACP Fixed Angle Cervical Screw DIA.4.5mm 12mm
00193082001031VELOX ACP Fixed Angle Cervical Screw DIA.4mm 18mm
00193082001024VELOX ACP Fixed Angle Cervical Screw DIA.4mm 16mm
00193082001017VELOX ACP Fixed Angle Cervical Screw DIA.4mm 14mm
00193082001000VELOX ACP Fixed Angle Cervical Screw DIA.4mm 12mm
00193082000997VELOX Anterior Cervical Plate - 4 Level, 96mm long
00193082000980VELOX Anterior Cervical Plate - 4 Level, 92mm long
00193082000973VELOX Anterior Cervical Plate - 4 Level, 88mm long
00193082000966VELOX Anterior Cervical Plate - 4 Level, 84mm long
00193082000959VELOX Anterior Cervical Plate - 4 Level, 80mm long
00193082000942VELOX Anterior Cervical Plate - 4 Level, 76mm long
00193082000935VELOX Anterior Cervical Plate - 4 Level, 72mm long
00193082000928VELOX Anterior Cervical Plate - 4 Level, 68mm long

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