ALLTUM FS1-4012

GUDID 00193082000416

ALLTUM ACP Screw - Fixed, DIA.4 L12mm

SPINECRAFT, LLC

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable
Primary Device ID00193082000416
NIH Device Record Key68eb1631-4999-442b-ad31-1c2e173a879b
Commercial Distribution StatusIn Commercial Distribution
Brand NameALLTUM
Version Model NumberFS1-4012
Catalog NumberFS1-4012
Company DUNS783908713
Company NameSPINECRAFT, LLC
Device Count1
DM Exempttrue
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 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
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
GS100193082000416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00193082000416]

Moist Heat or Steam Sterilization

[00193082000416]

Moist Heat or Steam Sterilization

[00193082000416]

Moist Heat or Steam Sterilization

[00193082000416]

Moist Heat or Steam Sterilization

[00193082000416]

Moist Heat or Steam Sterilization

[00193082000416]

Moist Heat or Steam Sterilization

[00193082000416]

Moist Heat or Steam Sterilization

[00193082000416]

Moist Heat or Steam Sterilization

[00193082000416]

Moist Heat or Steam Sterilization

[00193082000416]

Moist Heat or Steam Sterilization

[00193082000416]

Moist Heat or Steam Sterilization

[00193082000416]

Moist Heat or Steam Sterilization

[00193082000416]

Moist Heat or Steam Sterilization

[00193082000416]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-15

On-Brand Devices [ALLTUM]

00193082077838ALLTUM Plate Bender
00193082077821Combination Screwdriver w/ Solid Pin
00193082077807Cam Locker w/ Stainless Steel Sleeve
00193082077791Cam Locker w/ Titanium Sleeve
00193082077784ALLTUM Screw Remover
00193082077777ALLTUM Screw Extractor
00193082077760ALLTUM Variable Angle Drill Guide
00193082077753Screw Removal Sleeve
00193082077746ALLTUM Screwdriver
00193082077739ALLTUM Dia.4.5mm Screw Caddy
00193082077722ALLTUM Dia.4.0mm Screw Caddy
00193082077715ALLTUM Four Level Plate Caddy
00193082077708ALLTUM Three Level Plate Caddy
00193082077692ALLTUM One and Two Level Plate Caddy
00193082077685ALLTUM ACP System, Implants and Instruments Case
00193082000560ALLTUM ACP Screw - Variable, DIA.4.5 L18mm
00193082000553ALLTUM ACP Screw - Variable, DIA.4.5 L16mm
00193082000546ALLTUM ACP Screw - Variable, DIA.4.5 L14mm
00193082000539ALLTUM ACP Screw - Variable, DIA.4.5 L12mm
00193082000522ALLTUM ACP Screw - Variable, DIA.4 L18mm
00193082000515ALLTUM ACP Screw - Variable, DIA.4 L16mm
00193082000508ALLTUM ACP Screw - Variable, DIA.4 L14mm
00193082000492ALLTUM ACP Screw - Variable, DIA.4 L12mm
00193082000485ALLTUM ACP Screw - Fixed, DIA.4.5 L18mm
00193082000478ALLTUM ACP Screw - Fixed, DIA.4.5 L16mm
00193082000461ALLTUM ACP Screw - Fixed, DIA.4.5 L14mm
00193082000454ALLTUM ACP Screw - Fixed, DIA.4.5 L12mm
00193082000447ALLTUM ACP Screw - Fixed, DIA.4 L18mm
00193082000430ALLTUM ACP Screw - Fixed, DIA.4 L16mm
00193082000423ALLTUM ACP Screw - Fixed, DIA.4 L14mm
00193082000416ALLTUM ACP Screw - Fixed, DIA.4 L12mm
00193082000409ALLTUM Anterior Cervical Plate - 4 Levels, L96mm
00193082000393ALLTUM Anterior Cervical Plate - 4 Levels, L92mm
00193082000386ALLTUM Anterior Cervical Plate - 4 Levels, L88mm
00193082000379ALLTUM Anterior Cervical Plate - 4 Levels, L84mm
00193082000362ALLTUM Anterior Cervical Plate - 4 Levels, L80mm
00193082000355ALLTUM Anterior Cervical Plate - 4 Levels, L76mm
00193082000348ALLTUM Anterior Cervical Plate - 4 Levels, L72mm
00193082000331ALLTUM Anterior Cervical Plate - 4 Levels, L68mm
00193082000324ALLTUM Anterior Cervical Plate - 4 Levels, L64mm
00193082000317ALLTUM Anterior Cervical Plate - 4 Levels, L60mm
00193082000300ALLTUM Anterior Cervical Plate - 3 Levels, L69mm
00193082000294ALLTUM Anterior Cervical Plate - 3 Levels, L66mm
00193082000287ALLTUM Anterior Cervical Plate - 3 Levels, L63mm
00193082000270ALLTUM Anterior Cervical Plate - 3 Levels, L60mm
00193082000263ALLTUM Anterior Cervical Plate - 3 Levels, L57mm
00193082000256ALLTUM Anterior Cervical Plate - 3 Levels, L54mm
00193082000249ALLTUM Anterior Cervical Plate - 3 Levels, L51mm
00193082000232ALLTUM Anterior Cervical Plate - 3 Levels, L48mm
00193082000225ALLTUM Anterior Cervical Plate - 3 Levels, L45mm
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