Aranax Anterior Cervical Plating System

GUDID M697X0861416SDSTR1

Ø4.00 VARIABLE SELF-DRILLING SCREW, 16 mm

Xtant Medical Holdings, Inc.

Spinal fixation plate, non-bioabsorbable
Primary Device IDM697X0861416SDSTR1
NIH Device Record Key0ac2c2b4-26fb-481c-a21f-b1e6c53dd08b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAranax Anterior Cervical Plating System
Version Model NumberX086-1416SD-STR
Company DUNS081224143
Company NameXtant Medical Holdings, Inc.
Device Count2
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 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

Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM697X0861416SDSTR0 [Unit of Use]
HIBCCM697X0861416SDSTR1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

[M697X0861416SDSTR1]

Radiation Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-06-03
Device Publish Date2015-12-09

On-Brand Devices [Aranax Anterior Cervical Plating System]

M697X0861718STSTR1Ø4.25 FIXED SELF-TAPPING SCREW, 18 mm
M697X0861716STSTR1Ø4.25 FIXED SELF-TAPPING SCREW, 16 mm
M697X0861714STSTR1Ø4.25 FIXED SELF-TAPPING SCREW, 14 mm
M697X0861712STSTR1Ø4.25 FIXED SELF-TAPPING SCREW, 12 mm
M697X0861618STSTR1Ø4.00 FIXED SELF-TAPPING SCREW, 18 mm
M697X0861618SDSTR1Ø4.00 FIXED SELF-DRILLING SCREW, 18 mm
M697X0861616STSTR1Ø4.00 FIXED SELF-TAPPING SCREW, 16 mm
M697X0861616SDSTR1Ø4.00 FIXED SELF-DRILLING SCREW, 16 mm
M697X0861614STSTR1Ø4.00 FIXED SELF-TAPPING SCREW, 14 mm
M697X0861614SDSTR1Ø4.00 FIXED SELF-DRILLING SCREW, 14 mm
M697X0861612STSTR1Ø4.00 FIXED SELF-TAPPING SCREW, 12 mm
M697X0861612SDSTR1Ø4.00 FIXED SELF-DRILLING SCREW, 12 mm
M697X0861518STSTR1Ø4.25 VARIABLE SELF-TAPPING SCREW, 18 mm
M697X0861516STSTR1Ø4.25 VARIABLE SELF-TAPPING SCREW, 16 mm
M697X0861514STSTR1Ø4.25 VARIABLE SELF-TAPPING SCREW, 14 mm
M697X0861512STSTR1Ø4.25 VARIABLE SELF-TAPPING SCREW, 12 mm
M697X0861418STSTR1Ø4.00 VARIABLE SELF-TAPPING SCREW, 18 mm
M697X0861418SDSTR1Ø4.00 VARIABLE SELF-DRILLING SCREW, 18 mm
M697X0861416STSTR1Ø4.00 VARIABLE SELF-TAPPING SCREW, 16 mm
M697X0861416SDSTR1Ø4.00 VARIABLE SELF-DRILLING SCREW, 16 mm
M697X0861414STSTR1Ø4.00 VARIABLE SELF-TAPPING SCREW, 14 mm
M697X0861414SDSTR1Ø4.00 VARIABLE SELF-DRILLING SCREW, 14 mm
M697X0861412STSTR1Ø4.00 VARIABLE SELF-TAPPING SCREW, 12 mm
M697X0861412SDSTR1Ø4.00 VARIABLE SELF-DRILLING SCREW, 12 mm
M697X0861384STR1FOUR-LEVEL CERVICAL PLATE, 84 mm (95)
M697X0861380STR1FOUR-LEVEL CERVICAL PLATE, 80 mm (91)
M697X0861376STR1FOUR-LEVEL CERVICAL PLATE, 76 mm (87)
M697X0861372STR1FOUR-LEVEL CERVICAL PLATE, 72 mm (83)
M697X0861368STR1FOUR-LEVEL CERVICAL PLATE, 68 mm (79)
M697X0861364STR1FOUR-LEVEL CERVICAL PLATE, 64 mm (75)
M697X0861360STR1FOUR-LEVEL CERVICAL PLATE, 60 mm (71)
M697X0861356STR1FOUR-LEVEL CERVICAL PLATE, 56 mm (67)
M697X0861352STR1FOUR-LEVEL CERVICAL PLATE, 52 mm (63)
M697X0861348STR1FOUR-LEVEL CERVICAL PLATE, 48 mm (59)
M697X0861344STR1FOUR-LEVEL CERVICAL PLATE, 44 mm (55)
M697X0861266STR1THREE-LEVEL CERVICAL PLATE, 66 mm (77)
M697X0861263STR1THREE-LEVEL CERVICAL PLATE, 63 mm (74)
M697X0861260STR1THREE-LEVEL CERVICAL PLATE, 60 mm (71)
M697X0861257STR1THREE-LEVEL CERVICAL PLATE, 57 mm (68)
M697X0861254STR1THREE-LEVEL CERVICAL PLATE, 54 mm (65)
M697X0861251STR1THREE-LEVEL CERVICAL PLATE, 51 mm (62)
M697X0861248STR1THREE-LEVEL CERVICAL PLATE, 48 mm (59)
M697X0861245STR1THREE-LEVEL CERVICAL PLATE, 45 mm (56)
M697X0861242STR1THREE-LEVEL CERVICAL PLATE, 42 mm (53)
M697X0861239STR1THREE-LEVEL CERVICAL PLATE, 39 mm (50)
M697X0861236STR1THREE-LEVEL CERVICAL PLATE, 36 mm (47)
M697X0861233STR1THREE-LEVEL CERVICAL PLATE, 33 mm (44)
M697X0861143STR1TWO-LEVEL CERVICAL PLATE, 43 mm (54)
M697X0861140STR1TWO-LEVEL CERVICAL PLATE, 40 mm (51)
M697X0861137STR1TWO-LEVEL CERVICAL PLATE, 37 mm (48)
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