Transcend

GUDID 00190376242897

TRANSCEND LIF PEEK SPACER, 6 x 26 x 50 mm, 10°

ALPHATEC SPINE, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00190376242897
• NIH Device Record Key: a3901564-a4d0-4cdd-a858-61bb7699d576
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transcend
• Version Model Number: 101-06265010-S
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Dimensions

• Width: 26 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376242897 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191311

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-18
• Device Publish Date: 2020-03-10

On-Brand Devices [Transcend]

• 00190376206882: TRANSCEND LIF PEEK SPACER, 12 x 22 x 60 mm, 0°
• 00190376206875: TRANSCEND LIF PEEK SPACER, 12 x 22 x 55 mm, 0°
• 00190376206868: TRANSCEND LIF PEEK SPACER, 12 x 22 x 50 mm, 0°
• 00190376206851: TRANSCEND LIF PEEK SPACER, 12 x 22 x 45 mm, 0°
• 00190376206844: TRANSCEND LIF PEEK SPACER, 12 x 18 x 60 mm, 0°
• 00190376206837: TRANSCEND LIF PEEK SPACER, 12 x 18 x 55 mm, 0°
• 00190376206820: TRANSCEND LIF PEEK SPACER, 12 x 18 x 50 mm, 0°
• 00190376206813: TRANSCEND LIF PEEK SPACER, 12 x 18 x 45 mm, 0°
• 00190376206790: TRANSCEND LIF PEEK SPACER, 10 x 22 x 60 mm, 0°
• 00190376206776: TRANSCEND LIF PEEK SPACER, 10 x 22 x 55 mm, 0°
• 00190376206752: TRANSCEND LIF PEEK SPACER, 10 x 22 x 50 mm, 0°
• 00190376206738: TRANSCEND LIF PEEK SPACER, 10 x 22 x 45 mm, 0°
• 00190376206714: TRANSCEND LIF PEEK SPACER, 10 x 18 x 60 mm, 0°
• 00190376206677: TRANSCEND LIF PEEK SPACER, 10 x 18 x 55 mm, 0°
• 00190376206660: TRANSCEND LIF PEEK SPACER, 10 x 18 x 50 mm, 0°
• 00190376206653: TRANSCEND LIF PEEK SPACER, 10 x 18 x 45 mm, 0°
• 00190376206646: TRANSCEND LIF PEEK SPACER, 8 x 22 x 60 mm, 10°
• 00190376206639: TRANSCEND LIF PEEK SPACER, 8 x 22 x 60 mm, 0°
• 00190376206622: TRANSCEND LIF PEEK SPACER, 8 x 22 x 55 mm, 10°
• 00190376206615: TRANSCEND LIF PEEK SPACER, 8 x 22 x 55 mm, 0°
• 00190376206608: TRANSCEND LIF PEEK SPACER, 8 x 22 x 50 mm, 10°
• 00190376206592: TRANSCEND LIF PEEK SPACER, 8 x 22 x 50 mm, 0°
• 00190376206585: TRANSCEND LIF PEEK SPACER, 8 x 22 x 45 mm, 10°
• 00190376206578: TRANSCEND LIF PEEK SPACER, 8 x 22 x 45 mm, 0°
• 00190376206561: TRANSCEND LIF PEEK SPACER, 8 x 18 x 60 mm, 10°
• 00190376206554: TRANSCEND LIF PEEK SPACER, 8 x 18 x 60 mm, 0°
• 00190376206547: TRANSCEND LIF PEEK SPACER, 8 x 18 x 55 mm, 10°
• 00190376206530: TRANSCEND LIF PEEK SPACER, 8 x 18 x 55 mm, 0°
• 00190376206523: TRANSCEND LIF PEEK SPACER, 8 x 18 x 50 mm, 10°
• 00190376206516: TRANSCEND LIF PEEK SPACER, 8 x 18 x 50 mm, 0°
• 00190376206509: TRANSCEND LIF PEEK SPACER, 8 x 18 x 45 mm, 10°
• 00190376206493: TRANSCEND LIF PEEK SPACER, 8 x 18 x 45 mm, 0°
• 00190376206486: TRANSCEND LIF PEEK SPACER, 6 x 22 x 60 mm, 10°
• 00190376206479: TRANSCEND LIF PEEK SPACER, 6 x 22 x 55 mm, 10°
• 00190376206462: TRANSCEND LIF PEEK SPACER, 6 x 22 x 50 mm, 10°
• 00190376206455: TRANSCEND LIF PEEK SPACER, 6 x 22 x 45 mm, 10°
• 00190376206448: TRANSCEND LIF PEEK SPACER, 6 x 18 x 60 mm, 10°
• 00190376206431: TRANSCEND LIF PEEK SPACER, 6 x 18 x 55 mm, 10°
• 00190376206424: TRANSCEND LIF PEEK SPACER, 6 x 18 x 50 mm, 10°
• 00190376206417: TRANSCEND LIF PEEK SPACER, 6 x 18 x 45 mm, 10°
• 00190376206400: TRANSCEND LIF PEEK SPACER, 4 x 22 x 60 mm, 10°
• 00190376206394: TRANSCEND LIF PEEK SPACER, 4 x 22 x 55 mm, 10°
• 00190376206387: TRANSCEND LIF PEEK SPACER, 4 x 22 x 50 mm, 10°
• 00190376206370: TRANSCEND LIF PEEK SPACER, 4 x 22 x 45 mm, 10°
• 00190376206363: TRANSCEND LIF PEEK SPACER, 4 x 18 x 60 mm, 10°
• 00190376206356: TRANSCEND LIF PEEK SPACER, 4 x 18 x 55 mm, 10°
• 00190376206349: TRANSCEND LIF PEEK SPACER, 4 x 18 x 50 mm, 10°
• 00190376206332: TRANSCEND LIF PEEK SPACER, 4 x 18 x 45 mm, 10°
• 00190376243276: TRANSCEND LIF PEEK SPACER, 12 x 26 x 60 mm, 10°
• 00190376243269: TRANSCEND LIF PEEK SPACER, 12 x 26 x 55 mm, 10°