Aranax Anterior Cervical Plating System

GUDID M697X0861416STSTR1

Ø4.00 VARIABLE SELF-TAPPING SCREW, 16 mm

Xtant Medical Holdings, Inc.

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 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 ID	M697X0861416STSTR1
NIH Device Record Key	aa0271a8-9e72-4ba4-88f4-feb1ad40602c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Aranax Anterior Cervical Plating System
Version Model Number	X086-1416ST-STR
Company DUNS	081224143
Company Name	Xtant Medical Holdings, Inc.
Device Count	2
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter
Outer Diameter	4 Millimeter
Length	16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M697X0861416STSTR0 [Unit of Use]
HIBCC	M697X0861416STSTR1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K150834

FDA Product Code

KWQ	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

[M697X0861416STSTR1]

Radiation Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2021-06-03
Device Publish Date	2015-12-09

On-Brand Devices [Aranax Anterior Cervical Plating System]

M697X0861718STSTR1	Ø4.25 FIXED SELF-TAPPING SCREW, 18 mm
M697X0861716STSTR1	Ø4.25 FIXED SELF-TAPPING SCREW, 16 mm
M697X0861714STSTR1	Ø4.25 FIXED SELF-TAPPING SCREW, 14 mm
M697X0861712STSTR1	Ø4.25 FIXED SELF-TAPPING SCREW, 12 mm
M697X0861618STSTR1	Ø4.00 FIXED SELF-TAPPING SCREW, 18 mm
M697X0861618SDSTR1	Ø4.00 FIXED SELF-DRILLING SCREW, 18 mm
M697X0861616STSTR1	Ø4.00 FIXED SELF-TAPPING SCREW, 16 mm
M697X0861616SDSTR1	Ø4.00 FIXED SELF-DRILLING SCREW, 16 mm
M697X0861614STSTR1	Ø4.00 FIXED SELF-TAPPING SCREW, 14 mm
M697X0861614SDSTR1	Ø4.00 FIXED SELF-DRILLING SCREW, 14 mm
M697X0861612STSTR1	Ø4.00 FIXED SELF-TAPPING SCREW, 12 mm
M697X0861612SDSTR1	Ø4.00 FIXED SELF-DRILLING SCREW, 12 mm
M697X0861518STSTR1	Ø4.25 VARIABLE SELF-TAPPING SCREW, 18 mm
M697X0861516STSTR1	Ø4.25 VARIABLE SELF-TAPPING SCREW, 16 mm
M697X0861514STSTR1	Ø4.25 VARIABLE SELF-TAPPING SCREW, 14 mm
M697X0861512STSTR1	Ø4.25 VARIABLE SELF-TAPPING SCREW, 12 mm
M697X0861418STSTR1	Ø4.00 VARIABLE SELF-TAPPING SCREW, 18 mm
M697X0861418SDSTR1	Ø4.00 VARIABLE SELF-DRILLING SCREW, 18 mm
M697X0861416STSTR1	Ø4.00 VARIABLE SELF-TAPPING SCREW, 16 mm
M697X0861416SDSTR1	Ø4.00 VARIABLE SELF-DRILLING SCREW, 16 mm
M697X0861414STSTR1	Ø4.00 VARIABLE SELF-TAPPING SCREW, 14 mm
M697X0861414SDSTR1	Ø4.00 VARIABLE SELF-DRILLING SCREW, 14 mm
M697X0861412STSTR1	Ø4.00 VARIABLE SELF-TAPPING SCREW, 12 mm
M697X0861412SDSTR1	Ø4.00 VARIABLE SELF-DRILLING SCREW, 12 mm
M697X0861384STR1	FOUR-LEVEL CERVICAL PLATE, 84 mm (95)
M697X0861380STR1	FOUR-LEVEL CERVICAL PLATE, 80 mm (91)
M697X0861376STR1	FOUR-LEVEL CERVICAL PLATE, 76 mm (87)
M697X0861372STR1	FOUR-LEVEL CERVICAL PLATE, 72 mm (83)
M697X0861368STR1	FOUR-LEVEL CERVICAL PLATE, 68 mm (79)
M697X0861364STR1	FOUR-LEVEL CERVICAL PLATE, 64 mm (75)
M697X0861360STR1	FOUR-LEVEL CERVICAL PLATE, 60 mm (71)
M697X0861356STR1	FOUR-LEVEL CERVICAL PLATE, 56 mm (67)
M697X0861352STR1	FOUR-LEVEL CERVICAL PLATE, 52 mm (63)
M697X0861348STR1	FOUR-LEVEL CERVICAL PLATE, 48 mm (59)
M697X0861344STR1	FOUR-LEVEL CERVICAL PLATE, 44 mm (55)
M697X0861266STR1	THREE-LEVEL CERVICAL PLATE, 66 mm (77)
M697X0861263STR1	THREE-LEVEL CERVICAL PLATE, 63 mm (74)
M697X0861260STR1	THREE-LEVEL CERVICAL PLATE, 60 mm (71)
M697X0861257STR1	THREE-LEVEL CERVICAL PLATE, 57 mm (68)
M697X0861254STR1	THREE-LEVEL CERVICAL PLATE, 54 mm (65)
M697X0861251STR1	THREE-LEVEL CERVICAL PLATE, 51 mm (62)
M697X0861248STR1	THREE-LEVEL CERVICAL PLATE, 48 mm (59)
M697X0861245STR1	THREE-LEVEL CERVICAL PLATE, 45 mm (56)
M697X0861242STR1	THREE-LEVEL CERVICAL PLATE, 42 mm (53)
M697X0861239STR1	THREE-LEVEL CERVICAL PLATE, 39 mm (50)
M697X0861236STR1	THREE-LEVEL CERVICAL PLATE, 36 mm (47)
M697X0861233STR1	THREE-LEVEL CERVICAL PLATE, 33 mm (44)
M697X0861143STR1	TWO-LEVEL CERVICAL PLATE, 43 mm (54)
M697X0861140STR1	TWO-LEVEL CERVICAL PLATE, 40 mm (51)
M697X0861137STR1	TWO-LEVEL CERVICAL PLATE, 37 mm (48)