APEX-DL Spine System 6000-410-5B-DL

GUDID 00193082051999

APEX-DL Large Polyaxial Screw and Iliac Connectors Caddy

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 ID00193082051999
NIH Device Record Keyd5e64642-5535-4b84-9b47-cc8cb705e908
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPEX-DL Spine System
Version Model Number6000-410-5B-DL
Catalog Number6000-410-5B-DL
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
GS100193082051999 [Primary]
GS100193082051999 [Primary]
GS100193082051999 [Primary]
GS100193082051999 [Primary]
GS100193082051999 [Primary]
GS100193082051999 [Primary]
GS100193082051999 [Primary]
GS100193082051999 [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

[00193082051999]

Moist Heat or Steam Sterilization


[00193082051999]

Moist Heat or Steam Sterilization


[00193082051999]

Moist Heat or Steam Sterilization


[00193082051999]

Moist Heat or Steam Sterilization


[00193082051999]

Moist Heat or Steam Sterilization


[00193082051999]

Moist Heat or Steam Sterilization


[00193082051999]

Moist Heat or Steam Sterilization


[00193082051999]

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 [APEX-DL Spine System]

00193082049873APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.7.00, 100mm, Self-Tapping
00193082049866APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.7.00, 90mm, Self-Tapping
00193082049859APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.7.00, 80mm, Self-Tapping
00193082049842APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.7.00, 70mm, Self-Tapping
00193082049835APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.7.00, 60mm, Self-Tapping
00193082049828APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.7.00, 55mm, Self-Tapping
00193082049811APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.7.00, 50mm, Self-Tapping
00193082049804APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.7.00, 45mm, Self-Tapping
00193082049798APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.7.00, 40mm, Self-Tapping
00193082049781APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.7.00, 35mm, Self-Tapping
00193082049774APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.7.00, 30mm, Self-Tapping
00193082049767APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.7.00, 25mm, Self-Tapping
00193082049750APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.6.25, 85mm, Self-Tapping
00193082049743APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.6.25, 80mm, Self-Tapping
00193082049736APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.6.25, 75mm, Self-Tapping
00193082049729APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.6.25, 70mm, Self-Tapping
00193082049712APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.6.25, 65mm, Self-Tapping
00193082049705APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.6.25, 60mm, Self-Tapping
00193082049699APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.6.25, 55mm, Self-Tapping
00193082049682APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.6.25, 50mm, Self-Tapping
00193082049675APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.6.25, 45mm, Self-Tapping
00193082049668APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.6.25, 40mm, Self-Tapping
00193082049651APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.6.25, 35mm, Self-Tapping
00193082049644APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.6.25, 30mm, Self-Tapping
00193082049637APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.6.25, 25mm, Self-Tapping
00193082049620APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.5.50, 85mm, Self-Tapping
00193082049613APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.5.50, 80mm, Self-Tapping
00193082049606APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.5.50, 75mm, Self-Tapping
00193082049590APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.5.50, 70mm, Self-Tapping
00193082049583APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.5.50, 65mm, Self-Tapping
00193082049576APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.5.50, 60mm, Self-Tapping
00193082049569APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.5.50, 55mm, Self-Tapping
00193082049552APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.5.50, 50mm, Self-Tapping
00193082049545APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.5.50, 45mm, Self-Tapping
00193082049538APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.5.50, 40mm, Self-Tapping
00193082049521APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.5.50, 35mm, Self-Tapping
00193082049514APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.5.50, 30mm, Self-Tapping
00193082049507APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.5.50, 25mm, Self-Tapping
00193082049491APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.4.75, 85mm, Self-Tapping
00193082049484APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.4.75, 80mm, Self-Tapping
00193082049477APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.4.75, 75mm, Self-Tapping
00193082049460APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.4.75, 70mm, Self-Tapping
00193082049453APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.4.75, 65mm, Self-Tapping
00193082049446APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.4.75, 60mm, Self-Tapping
00193082049439APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.4.75, 55mm, Self-Tapping
00193082049422APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.4.75, 50mm, Self-Tapping
00193082049415APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.4.75, 45mm, Self-Tapping
00193082049408APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.4.75, 40mm, Self-Tapping
00193082049392APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.4.75, 35mm, Self-Tapping
00193082049385APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.4.75, 30mm, Self-Tapping

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