ASTRA-OCT Spine System A3ZR-407-100K

GUDID 00193082110788

ASTRA-OCT Dia.4mm CoCr Z-Rod, 7mm Offset, 100mm

SPINECRAFT, LLC

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00193082110788
NIH Device Record Keye0f1c5a2-324a-40a2-ac67-590ae1cb8c5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameASTRA-OCT Spine System
Version Model NumberA3ZR-407-100K
Catalog NumberA3ZR-407-100K
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
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
GS100193082110788 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKGOrthosis, cervical pedicle screw spinal fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00193082110788]

Moist Heat or Steam Sterilization

[00193082110788]

Moist Heat or Steam Sterilization

[00193082110788]

Moist Heat or Steam Sterilization

[00193082110788]

Moist Heat or Steam Sterilization

[00193082110788]

Moist Heat or Steam Sterilization

[00193082110788]

Moist Heat or Steam Sterilization

[00193082110788]

Moist Heat or Steam Sterilization

[00193082110788]

Moist Heat or Steam Sterilization

[00193082110788]

Moist Heat or Steam Sterilization

[00193082110788]

Moist Heat or Steam Sterilization

[00193082110788]

Moist Heat or Steam Sterilization

[00193082110788]

Moist Heat or Steam Sterilization

[00193082110788]

Moist Heat or Steam Sterilization

[00193082110788]

Moist Heat or Steam Sterilization

[00193082110788]

Moist Heat or Steam Sterilization

[00193082110788]

Moist Heat or Steam Sterilization

[00193082110788]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-01
Device Publish Date2019-03-22

On-Brand Devices [ASTRA-OCT Spine System]

00193082111013ASTRA-OCT Dia.5.0mm Occipital Bone Screw, 18mm
00193082111006ASTRA-OCT Dia.5.0mm Occipital Bone Screw, 16mm
00193082110993ASTRA-OCT Dia.5.0mm Occipital Bone Screw, 14mm
00193082110986ASTRA-OCT Dia.5.0mm Occipital Bone Screw, 12mm
00193082110979ASTRA-OCT Dia.5.0mm Occipital Bone Screw, 10mm
00193082110962ASTRA-OCT Dia.5.0mm Occipital Bone Screw, 8mm
00193082110955ASTRA-OCT Dia.5.0mm Occipital Bone Screw, 6mm
00193082110948ASTRA-OCT Dia.4.5mm Occipital Bone Screw, 18mm
00193082110931ASTRA-OCT Dia.4.5mm Occipital Bone Screw, 16mm
00193082110924ASTRA-OCT Dia.4.5mm Occipital Bone Screw, 14mm
00193082110917ASTRA-OCT Dia.4.5mm Occipital Bone Screw, 12mm
00193082110900ASTRA-OCT Dia.4.5mm Occipital Bone Screw, 10mm
00193082110894ASTRA-OCT Dia.4.5mm Occipital Bone Screw, 8mm
00193082110887ASTRA-OCT Dia.4.5mm Occipital Bone Screw, 6mm
00193082110870ASTRA-OCT Adjustable Occipital Plate, 48mm
00193082110863ASTRA-OCT Adjustable Occipital Plate, 42mm
00193082110856ASTRA-OCT Adjustable Occipital Plate, 36mm
00193082110849ASTRA-OCT Adjustable Occipital Plate, 32mm
00193082110832ASTRA-OCT Dia.4mm CoCr Z-Rod, 9mm Offset, 325mm
00193082110825ASTRA-OCT Dia.4mm CoCr Z-Rod, 9mm Offset, 200mm
00193082110818ASTRA-OCT Dia.4mm CoCr Z-Rod, 9mm Offset, 100mm
00193082110801ASTRA-OCT Dia.4mm CoCr Z-Rod, 7mm Offset, 325mm
00193082110795ASTRA-OCT Dia.4mm CoCr Z-Rod, 7mm Offset, 200mm
00193082110788ASTRA-OCT Dia.4mm CoCr Z-Rod, 7mm Offset, 100mm
00193082110771ASTRA-OCT Dia.3.5mm CoCr Z-Rod, 9mm Offset, 325mm
00193082110764ASTRA-OCT Dia.3.5mm CoCr Z-Rod, 9mm Offset, 200mm
00193082110757ASTRA-OCT Dia.3.5mm CoCr Z-Rod, 9mm Offset, 100mm
00193082110740ASTRA-OCT Dia.3.5mm CoCr Z-Rod, 7mm Offset, 325mm
00193082110733ASTRA-OCT Dia.3.5mm CoCr Z-Rod, 7mm Offset, 200mm
00193082110726ASTRA-OCT Dia.3.5mm CoCr Z-Rod, 7mm Offset, 100mm
00193082110719ASTRA-OCT Dia.4mm Ti Z-Rod, 9mm Offset, 325mm
00193082110702ASTRA-OCT Dia.4mm Ti Z-Rod, 9mm Offset, 200mm
00193082110696ASTRA-OCT Dia.4mm Ti Z-Rod, 9mm Offset, 100mm
00193082110689ASTRA-OCT Dia.4mm Ti Z-Rod, 7mm Offset, 325mm
00193082110672ASTRA-OCT Dia.4mm Ti Z-Rod, 7mm Offset, 200mm
00193082110665ASTRA-OCT Dia.4mm Ti Z-Rod, 7mm Offset, 100mm
00193082110658ASTRA-OCT Dia.3.5mm Ti Z-Rod, 9mm Offset, 325mm
00193082110641ASTRA-OCT Dia.3.5mm Ti Z-Rod, 9mm Offset, 200mm
00193082110634ASTRA-OCT Dia.3.5mm Ti Z-Rod, 9mm Offset, 100mm
00193082110627ASTRA-OCT Dia.3.5mm Ti Z-Rod, 7mm Offset, 325mm
00193082110610ASTRA-OCT Dia.3.5mm Ti Z-Rod, 7mm Offset, 200mm
00193082110603ASTRA-OCT Dia.3.5mm Ti Z-Rod, 7mm Offset, 100mm
00193082110597ASTRA-OCT Cable Connector
00193082110580ASTRA-OCT Open Side-loading Angled Lateral Connector, 30mm
00193082110573ASTRA-OCT Open Side-loading Angled Lateral Connector, 25mm
00193082110566ASTRA-OCT Open Side-loading Angled Lateral Connector, 20mm
00193082110559ASTRA-OCT Open Side-loading Angled Lateral Connector, 15mm
00193082110542ASTRA-OCT Open Side-loading Angled Lateral Connector, 10mm
00193082110535ASTRA-OCT Open Side-loading Lateral Connector, 25mm
00193082110528ASTRA-OCT Open Side-loading Lateral Connector, 20mm
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