Unison®-C Anterior Cervical Fixation System 64-1612-12-7L

GUDID 00846468082437

Interbody Fusion Device, 16mm (W), 12mm (D), 12mm (H), 7° Lordosis

Pioneer Surgical Technology, Inc.

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• Primary Device ID: 00846468082437
• NIH Device Record Key: b4af5c60-83fa-4af7-ae80-886bcb1ea2d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unison®-C Anterior Cervical Fixation System
• Version Model Number: 64-1612-12-7L
• Catalog Number: 64-1612-12-7L
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468082437 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170830

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-07-03

On-Brand Devices [Unison®-C Anterior Cervical Fixation System]

• 00846468083816: Rasping Trial Case
• 00846468083809: Screw Caddy
• 00846468083793: Instrument Case
• 00846468083540: Self-Tapping Screw, Ø 3.9mm, 15mm (L)
• 00846468083533: Self-Tapping Screw, Ø 3.9mm, 14mm (L)
• 00846468083526: Self-Tapping Screw, Ø 3.9mm, 13mm (L)
• 00846468083519: Self-Tapping Screw, Ø 3.9mm, 12mm (L)
• 00846468083502: Self-Tapping Screw, Ø 3.4mm, 16mm (L)
• 00846468083496: Self-Tapping Screw, Ø 3.4mm, 15mm (L)
• 00846468083489: Self-Tapping Screw, Ø 3.4mm, 14mm (L)
• 00846468083472: Self-Tapping Screw, Ø 3.4mm, 13mm (L)
• 00846468083465: Self-Tapping Screw, Ø 3.4mm, 12mm (L)
• 00846468083458: Self-Drilling Screw, Ø 3.4mm, 16mm (L)
• 00846468083441: Self-Drilling Screw, Ø 3.4mm, 15mm (L)
• 00846468083434: Self-Drilling Screw, Ø 3.4mm, 14mm (L)
• 00846468083427: Self-Drilling Screw, Ø 3.4mm, 13mm (L)
• 00846468083410: Self-Drilling Screw, Ø 3.4mm, 12mm (L)
• 00846468083403: Interbody Fusion Device, 22mm (W), 16mm (D), 11mm (H), 7° Lordosis
• 00846468083397: Interbody Fusion Device, 22mm (W), 16mm (D), 10mm (H), 7° Lordosis
• 00846468083380: Interbody Fusion Device, 22mm (W), 16mm (D), 9mm (H), 7° Lordosis
• 00846468083373: Interbody Fusion Device, 22mm (W), 16mm (D), 8mm (H), 7° Lordosis
• 00846468083366: Interbody Fusion Device, 22mm (W), 16mm (D), 7mm (H), 7° Lordosis
• 00846468083359: Interbody Fusion Device, 22mm (W), 16mm (D), 6mm (H), 7° Lordosis
• 00846468083342: Interbody Fusion Device, 22mm (W), 16mm (D), 12mm (H), 0° Lordosis
• 00846468083335: Interbody Fusion Device, 22mm (W), 16mm (D), 11mm (H), 0° Lordosis
• 00846468083328: Interbody Fusion Device, 22mm (W), 16mm (D), 10mm (H), 0° Lordosis
• 00846468083311: Interbody Fusion Device, 22mm (W), 16mm (D), 9mm (H), 0° Lordosis
• 00846468083304: Interbody Fusion Device, 22mm (W), 16mm (D), 8mm (H), 0° Lordosis
• 00846468083298: Interbody Fusion Device, 22mm (W), 16mm (D), 7mm (H), 0° Lordosis
• 00846468083281: Interbody Fusion Device, 22mm (W), 16mm (D), 6mm (H), 0° Lordosis
• 00846468083274: Interbody Fusion Device, 22mm (W), 16mm (D), 12mm (H), 7° Lordosis
• 00846468083267: Interbody Fusion Device, 22mm (W), 16mm (D), 11mm (H), 7° Lordosis
• 00846468083250: Interbody Fusion Device, 22mm (W), 16mm (D), 10mm (H), 7° Lordosis
• 00846468083243: Interbody Fusion Device, 22mm (W), 14mm (D), 9mm (H), 7° Lordosis
• 00846468083236: Interbody Fusion Device, 22mm (W), 14mm (D), 8mm (H), 7° Lordosis
• 00846468083229: Interbody Fusion Device, 22mm (W), 14mm (D), 7mm (H), 7° Lordosis
• 00846468083212: Interbody Fusion Device, 22mm (W), 14mm (D), 6mm (H), 7° Lordosis
• 00846468083205: Interbody Fusion Device, 22mm (W), 16mm (D), 12mm (H), 0° Lordosis
• 00846468083199: Interbody Fusion Device, 22mm (W), 16mm (D), 11mm (H), 0° Lordosis
• 00846468083182: Interbody Fusion Device, 22mm (W), 16mm (D), 10mm (H), 0° Lordosis
• 00846468083175: Interbody Fusion Device, 22mm (W), 14mm (D), 9mm (H), 0° Lordosis
• 00846468083168: Interbody Fusion Device, 22mm (W), 14mm (D), 8mm (H), 0° Lordosis
• 00846468083151: Interbody Fusion Device, 22mm (W), 14mm (D), 7mm (H), 0° Lordosis
• 00846468083144: Interbody Fusion Device, 22mm (W), 14mm (D), 6mm (H), 0° Lordosis
• 00846468083137: Interbody Fusion Device, 20mm (W), 16mm (D), 12mm (H), 7° Lordosis
• 00846468083120: Interbody Fusion Device, 20mm (W), 16mm (D), 11mm (H), 7° Lordosis
• 00846468083113: Interbody Fusion Device, 20mm (W), 16mm (D), 10mm (H), 7° Lordosis
• 00846468083106: Interbody Fusion Device, 20mm (W), 16mm (D), 9mm (H), 7° Lordosis
• 00846468083090: Interbody Fusion Device, 20mm (W), 16mm (D), 8mm (H), 7° Lordosis
• 00846468083083: Interbody Fusion Device, 20mm (W), 16mm (D), 7mm (H), 7° Lordosis