Aranax Anterior Cervical Plating System

GUDID M697X08600021

Aranax System Carrying Case

Xtant Medical Holdings, Inc.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: M697X08600021
• NIH Device Record Key: a944d620-cd41-4c81-8a0a-3c69f4b84bca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aranax Anterior Cervical Plating System
• Version Model Number: X086-0002
• Company DUNS: 081224143
• Company Name: Xtant Medical Holdings, Inc.
• Device Count: 1
• DM Exempt: false
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	M697X08600021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150834

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

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)