Insignia

GUDID 00190376475325

Trial Drill Guide, 10mm

ALPHATEC SPINE, INC.

Surgical implant/trial-implant/sizer holder, reusable

• Primary Device ID: 00190376475325
• NIH Device Record Key: c4ccf417-9a84-4260-a319-881bbe37e283
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insignia
• Version Model Number: 237-4251510
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, 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(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376475325 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222973

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

Sterilization

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

[00190376475325]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-01-13
• Device Publish Date: 2023-01-05

On-Brand Devices [Insignia]

• 00190376274737: 20° Trial Drill Guide, 12mm
• 00190376274720: 20° Trial Drill Guide, 11mm
• 00190376274713: 20° Trial Drill Guide, 10mm
• 00190376274706: 20° Trial Drill Guide, 9mm
• 00190376274690: 20° Trial Drill Guide, 8mm
• 00190376274683: 20° Trial Drill Guide, 7mm
• 00190376274676: 20° Trial Drill Guide, 6mm
• 00190376274669: 20° Trial Drill Guide, 5mm
• 00190376274652: 15° Trial Drill Guide, 12mm
• 00190376274645: 15° Trial Drill Guide, 11mm
• 00190376274638: 15° Trial Drill Guide, 10mm
• 00190376274621: 15° Trial Drill Guide, 9mm
• 00190376274614: 15° Trial Drill Guide, 8mm
• 00190376274607: 15° Trial Drill Guide, 7mm
• 00190376274591: 15° Trial Drill Guide, 6mm
• 00190376274584: 15° Trial Drill Guide, 5mm
• 00190376274577: 12° Trial Drill Guide, 12mm
• 00190376274560: 12° Trial Drill Guide, 11mm
• 00190376274553: 12° Trial Drill Guide, 10mm
• 00190376274546: 12° Trial Drill Guide, 9mm
• 00190376274539: 12° Trial Drill Guide, 8mm
• 00190376274522: 12° Trial Drill Guide, 7mm
• 00190376274515: 12° Trial Drill Guide, 6mm
• 00190376274508: 12° Trial Drill Guide, 5mm
• 00190376274492: 10° Trial Drill Guide, 12mm
• 00190376274485: 10° Trial Drill Guide, 11mm
• 00190376274478: 10° Trial Drill Guide, 10mm
• 00190376274461: 10° Trial Drill Guide, 9mm
• 00190376274454: 10° Trial Drill Guide, 8mm
• 00190376274447: 10° Trial Drill Guide, 7mm
• 00190376274430: 10° Trial Drill Guide, 6mm
• 00190376274423: 10° Trial Drill Guide, 5mm
• 00190376274416: Quad Barrel Trial Drill Guide, 12mm
• 00190376274409: Quad Barrel Trial Drill Guide, 11mm
• 00190376274393: Quad Barrel Trial Drill Guide, 10mm
• 00190376274386: Quad Barrel Trial Drill Guide, 9mm
• 00190376274379: Quad Barrel Trial Drill Guide, 8mm
• 00190376274362: Quad Barrel Trial Drill Guide, 7mm
• 00190376274355: Quad Barrel Trial Drill Guide, 6mm
• 00190376274348: Quad Barrel Trial Drill Guide, 5mm
• 00190376271040: Single Level Inserter
• 00190376268743: Insignia, ACP, 1-Level, 24 mm
• 00190376268491: Insignia, ACP, 1-Level, 23 mm
• 00190376268484: Insignia, ACP, 1-Level, 22 mm
• 00190376268477: Insignia, ACP, 1-Level, 21 mm
• 00190376268460: Insignia, ACP, 1-Level, 20 mm
• 00190376268453: Insignia, ACP, 1-Level, 19 mm
• 00190376268446: Insignia, ACP, 1-Level, 18 mm
• 00190376268439: Insignia, ACP, 1-Level, 17 mm
• 00190376268422: Insignia, ACP, 1-Level, 16 mm