Spider Cervical Plating System

GUDID M697N60000145LT1

4mm X 12mm Screw (Fixed), LOW TORQUE

Xtant Medical Holdings, Inc.

Spinal fixation plate, non-bioabsorbable
Primary Device IDM697N60000145LT1
NIH Device Record Key65de2123-149e-4c29-8493-21bd20fddb19
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpider Cervical Plating System
Version Model NumberN60000145LT
Company DUNS081224143
Company NameXtant Medical Holdings, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Customer Support Contacts

Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com

Device Dimensions

Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM697N60000145LT1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

[M697N60000145LT1]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-06-03
Device Publish Date2015-09-04

On-Brand Devices [Spider Cervical Plating System]

M697X00900200Assembly, Single Barrel All-In-One Drill Guide
M697X00900100Assembly, Self Retaining Double Barrel Guide
M697X00900010Assembly, Double Barrel Guide
M697N600019940Spider System Fixation Pin, Barbed, .70
M697N600019930Spider System Fixation Pin, Barbed, .60
M697N600019920Spider System Temporary Fixation Pin, .70
M697N600015200ASSEMBLY, SELF-CENTERING BONE AWL
M697N60001514014mm SPIDER BONE AWL
M697N60001512012mm SPIDER BONE AWL
M697N600015030NON-RATCHETING T-HANDLE MINI AO DRIVER
M697N600015020RATCHETING MINI AO DRIVER
M697N600015000STRAIGHT SCREWDRIVER ASSEMBLY
M697N600010650Spider 4-Level Cervical Plate Caddy
M697N60001064LTCS0Spider Low Torque Screw Caddy Set, Spider System
M697N60001064LT0Spider Low Torque Screw Caddy, Spider System
M697N600010640Spider Screw Caddy, Spider System
M697N600010630Spider Cervical Plate Caddy
M697N600010500Single Barrel Fixed Drill Guide Assembly
M697N60001018LTCS0Spider 18mm Low Torque Screw Caddy Set, Spider System
M697N60001018LT0Spider 18mm Low Torque Screw Caddy, Spider System
M697N60001018018mm Spider Cervical Plate Screw Caddy, Spider System
M697N600009270AO Hex Driver
M697N600009260AO Hex Driver Assy
M697N600004820Neuro Caliper
M697N600002010Sterilization Case, Spider System
M697N600001920Plate Bender
M697N600001900Screw Removal Device
M697N600001800Single Barrel Variable Drill Guide Assembly
M697N60000177016mm Drill Bit
M697N60000176014mm Drill Bit
M697N60000175012mm Drill Bit
M697N6000017004mm Tap Assembly
M697N600001650Bone Awl Assembly
M697N600001600Screwdriver Assembly
M697N600001590Spider System Threaded Temporary Fixation Pin
M697N60000152LT14.25mm x 16mm Screw (Fixed), LOW TORQUE
M697N6000015214.25mm x 16mm Screw (Fixed)
M697N60000151LT14.25mm x 14mm Screw (Fixed), LOW TORQUE
M697N6000015114.25mm x 14mm Screw (Fixed)
M697N60000150LT14.25mm x 12mm Screw (Fixed), LOW TORQUE
M697N6000015014.25mm x 12mm Screw (Fixed)
M697N60000147LT14mm x 16mm Screw (Fixed), LOW TORQUE
M697N6000014714mm x 16mm Screw (Fixed)
M697N60000146LT14mm X 14mm Screw (Fixed), LOW TORQUE
M697N6000014614mm X 14mm Screw (Fixed)
M697N60000145LT14mm X 12mm Screw (Fixed), LOW TORQUE
M697N6000014514mm X 12mm Screw (Fixed)
M697N60000142LT14.25mm x 16mm Screw (Variable), LOW TORQUE
M697N6000014214.25mm x 16mm Screw (Variable)
M697N60000141LT14.25mm x 14mm Screw (Variable), LOW TORQUE
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