ATEC Lateral Navigation Disc Prep Instruments

GUDID 00190376541518

LIF NAV, TRIAL 6 x 18 x 65mm 10°

ALPHATEC SPINE, INC.

Spinal implant trial

• Primary Device ID: 00190376541518
• NIH Device Record Key: 35d4b8f4-d7c5-4570-9cac-148b84ec53fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATEC Lateral Navigation Disc Prep Instruments
• Version Model Number: 267-10-06186510-N
• 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
• 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	00190376541518 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223765

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00190376541518]

Moist Heat or Steam Sterilization

[00190376541518]

Moist Heat or Steam Sterilization

[00190376541518]

Moist Heat or Steam Sterilization

[00190376541518]

Moist Heat or Steam Sterilization

[00190376541518]

Moist Heat or Steam Sterilization

[00190376541518]

Moist Heat or Steam Sterilization

[00190376541518]

Moist Heat or Steam Sterilization

[00190376541518]

Moist Heat or Steam Sterilization

[00190376541518]

Moist Heat or Steam Sterilization

[00190376541518]

Moist Heat or Steam Sterilization

[00190376541518]

Moist Heat or Steam Sterilization

[00190376541518]

Moist Heat or Steam Sterilization

[00190376541518]

Moist Heat or Steam Sterilization

[00190376541518]

Moist Heat or Steam Sterilization

[00190376541518]

Moist Heat or Steam Sterilization

[00190376541518]

Moist Heat or Steam Sterilization

[00190376541518]

Moist Heat or Steam Sterilization

[00190376541518]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-26
• Device Publish Date: 2024-12-18

On-Brand Devices [ATEC Lateral Navigation Disc Prep Instruments]

• 00190376476131: LIF Nav Primary Dilator Stimulating
• 00190376595573: LIF Navigated Disc Prep
• 00190376541686: LIF NAV, SHAVER 14mm
• 00190376541679: LIF NAV, SHAVER 12mm
• 00190376541662: LIF NAV, SHAVER 10mm
• 00190376541655: LIF NAV, SHAVER 8mm
• 00190376541617: LIF NAV, ENDPLATE SCRAPER SS 10mm
• 00190376541594: LIF NAV, COBB 18mm
• 00190376541587: LIF NAV, COBB 10mm
• 00190376541570: LIF NAV, TRIAL 12 x 18 x 65mm 10°
• 00190376541556: LIF NAV, TRIAL 10 x 18 x 65mm 10°
• 00190376541532: LIF NAV, TRIAL 8 x 18 x 65mm 10°
• 00190376541525: LIF NAV, TRIAL 8 x 18 x 65mm 0°
• 00190376541518: LIF NAV, TRIAL 6 x 18 x 65mm 10°
• 00190376541501: LIF NAV, TRIAL 6 x 18 x 65mm 0°
• 00190376541471: LIF NAV, OSTEOTOME 10mm
• 00190376508108: T-HANDLE, LATCHING, 1/4" HUDSON