Calibrate

GUDID 00190376472140

LTX ANGLED INSERTER, OFFSET LEFT

ALPHATEC SPINE, INC.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00190376472140
• NIH Device Record Key: 5b3eb904-b9f4-432c-8787-cc01d24bfc74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calibrate
• Version Model Number: 258-310
• 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
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376472140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222455

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00190376472140]

Moist Heat or Steam Sterilization

[00190376472140]

Moist Heat or Steam Sterilization

[00190376472140]

Moist Heat or Steam Sterilization

[00190376472140]

Moist Heat or Steam Sterilization

[00190376472140]

Moist Heat or Steam Sterilization

[00190376472140]

Moist Heat or Steam Sterilization

[00190376472140]

Moist Heat or Steam Sterilization

[00190376472140]

Moist Heat or Steam Sterilization

[00190376472140]

Moist Heat or Steam Sterilization

[00190376472140]

Moist Heat or Steam Sterilization

[00190376472140]

Moist Heat or Steam Sterilization

[00190376472140]

Moist Heat or Steam Sterilization

[00190376472140]

Moist Heat or Steam Sterilization

[00190376472140]

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 [Calibrate]

• 00190376474786: LTX REMOVAL TOOL
• 00190376474779: LTX EXPANSION DRIVER AXIAL, 26 in-lbs
• 00190376474762: LTX EXPANSION DRIVER T-HANDLE, 26 in-lbs
• 00190376474205: LTX TRIAL, 6 x 22 x 60 mm, 20°
• 00190376474199: LTX TRIAL, 6 x 22 x 60 mm, 15°
• 00190376473994: LTX SPACER, 6 x 22 x 60 mm, 20°
• 00190376473987: LTX SPACER, 6 x 22 x 60 mm, 15°
• 00190376473963: LTX SPACER, 6 x 22 x 55 mm, 20°
• 00190376473956: LTX SPACER, 6 x 22 x 55 mm, 15°
• 00190376473932: LTX SPACER, 6 x 22 x 50 mm, 20°
• 00190376473925: LTX SPACER, 6 x 22 x 50 mm, 15°
• 00190376473901: LTX SPACER, 6 x 22 x 45 mm, 20°
• 00190376473895: LTX SPACER, 6 x 22 x 45 mm, 15°
• 00190376473888: LTX SPACER, 6 x 18 x 60 mm, 20°
• 00190376473871: LTX SPACER, 6 x 18 x 60 mm, 15°
• 00190376473864: LTX SPACER, 6 x 18 x 55 mm, 20°
• 00190376473857: LTX SPACER, 6 x 18 x 55 mm, 15°
• 00190376473840: LTX SPACER, 6 x 18 x 50 mm, 20°
• 00190376473833: LTX SPACER, 6 x 18 x 50 mm, 15°
• 00190376473826: LTX SPACER, 6 x 18 x 45 mm, 20°
• 00190376473819: LTX SPACER, 6 x 18 x 45 mm, 15°
• 00190376472218: LTX GRAFT TUBE
• 00190376472201: LTX GRAFT TAMP
• 00190376472195: LTX GRAFT FUNNEL
• 00190376472164: LTX ATTACHMENT DRIVER
• 00190376472157: LTX Freehand Expansion Driver
• 00190376472140: LTX ANGLED INSERTER, OFFSET LEFT
• 00190376472133: LTX ANGLED INSERTER, OFFSET RIGHT
• 00190376472089: LTX INSERTER
• 00190376472072: LTX TRIAL, 6 x 22 x 60 mm, 30°
• 00190376472065: LTX TRIAL, 6 x 18 x 60 mm, 20°
• 00190376472058: LTX TRIAL, 6 x 18 x 60 mm, 15°
• 00190376474182: LTX Bone Screw, Ø5.5 mm x 60 mm
• 00190376474175: LTX Bone Screw, Ø5.5 mm x 55 mm
• 00190376474168: LTX Bone Screw, Ø5.5 mm x 50 mm
• 00190376474151: LTX Bone Screw, Ø5.5 mm x 45 mm
• 00190376474144: LTX Bone Screw, Ø5.5 mm x 40 mm
• 00190376474137: LTX Bone Screw, Ø5.5 mm x 35 mm
• 00190376474120: LTX Bone Screw, Ø5.5 mm x 30 mm
• 00190376474113: LTX Bone Screw, Ø5.5 mm x 25 mm
• 00190376474106: LTX Bone Screw, Ø5.0 mm x 60 mm
• 00190376474090: LTX Bone Screw, Ø5.0 mm x 55 mm
• 00190376474083: LTX Bone Screw, Ø5.0 mm x 50 mm
• 00190376474076: LTX Bone Screw, Ø5.0 mm x 45 mm
• 00190376474069: LTX Bone Screw, Ø5.0 mm x 40 mm
• 00190376474052: LTX Bone Screw, Ø5.0 mm x 35 mm
• 00190376474045: LTX Bone Screw, Ø5.0 mm x 30 mm
• 00190376474038: LTX Bone Screw, Ø5.0 mm x 25 mm
• 00190376474007: LTX HL SPACER, 6 x 22 x 60 mm, 30°
• 00190376473970: LTX HL SPACER, 6 x 22 x 55 mm, 30°