ATEC Lateral Navigation Instruments

GUDID 00190376476292

LIF NAV COBB 18mm

ALPHATEC SPINE, INC.

Bone lever/elevator, reusable

• Primary Device ID: 00190376476292
• NIH Device Record Key: 76ab8db0-f07d-4bca-b182-400c19c2056b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATEC Lateral Navigation Instruments
• Version Model Number: 266-12-000-18-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
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Dimensions

• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376476292 [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

[00190376476292]

Moist Heat or Steam Sterilization

[00190376476292]

Moist Heat or Steam Sterilization

[00190376476292]

Moist Heat or Steam Sterilization

[00190376476292]

Moist Heat or Steam Sterilization

[00190376476292]

Moist Heat or Steam Sterilization

[00190376476292]

Moist Heat or Steam Sterilization

[00190376476292]

Moist Heat or Steam Sterilization

[00190376476292]

Moist Heat or Steam Sterilization

[00190376476292]

Moist Heat or Steam Sterilization

[00190376476292]

Moist Heat or Steam Sterilization

[00190376476292]

Moist Heat or Steam Sterilization

[00190376476292]

Moist Heat or Steam Sterilization

[00190376476292]

Moist Heat or Steam Sterilization

[00190376476292]

Moist Heat or Steam Sterilization

[00190376476292]

Moist Heat or Steam Sterilization

[00190376476292]

Moist Heat or Steam Sterilization

[00190376476292]

Moist Heat or Steam Sterilization

[00190376476292]

Moist Heat or Steam Sterilization

[00190376476292]

Moist Heat or Steam Sterilization

[00190376476292]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-04
• Device Publish Date: 2023-08-26

On-Brand Devices [ATEC Lateral Navigation Instruments]

• 00190376523439: Alpha LIF Navigated Disc Prep
• 00190376522906: LIF NAV OSTEOTOME 14mm
• 00190376509792: LIF NAV, SHAVER 14mm
• 00190376509785: LIF NAV, SHAVER 12mm
• 00190376509778: LIF NAV, SHAVER 10mm
• 00190376509761: LIF NAV, SHAVER 8mm
• 00190376509754: LIF NAV, SHAVER 6mm
• 00190376494692: LIF NAV PRIMARY DILATOR
• 00190376477107: LIF NAV TRIAL 6 x 18 x 65 mm 10°
• 00190376476353: LIF NAV ENDPLATE SCRAPER 8mm
• 00190376476339: LIF NAV ENDPLATE SCRAPER SS 10mm
• 00190376476322: LIF NAV ENDPLATE SCRAPER SS 8mm
• 00190376476292: LIF NAV COBB 18mm
• 00190376476285: LIF NAV COBB 10mm
• 00190376476254: LIF NAV TRIAL 12 x 18 x 65 mm 10°
• 00190376476247: LIF NAV TRIAL 12 x 18 x 65 mm 0°
• 00190376476230: LIF NAV TRIAL 10 x 18 x 65 mm 10°
• 00190376476223: LIF NAV TRIAL 10 x 18 x 65 mm 0°
• 00190376476216: LIF NAV TRIAL 8 x 18 x 65 mm 10°
• 00190376476209: LIF NAV TRIAL 8 x 18 x 65 mm 0°
• 00190376476193: LIF NAV TRIAL 6 x 18 x 65 mm 0°
• 00190376476186: LIF NAV OSTEOTOME 12mm
• 00190376476179: LIF NAV OSTEOTOME 10mm
• 00190376476162: LIF NAV OSTEOTOME 8mm
• 00190376476155: LIF NAV PRIMARY DILATOR CANNULATED
• 00190376476070: LIF NAV ENDPLATE SCRAPER 10mm