ATEC Porous Ti

GUDID 00190376116587

ATEC POROUS Ti, PC, 5DEG, 10WIDE, 30L x 10P x 11A

ALPHATEC SPINE, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00190376116587
• NIH Device Record Key: 2ad78847-396f-4b4e-b2bf-ce3473534317
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATEC Porous Ti
• Version Model Number: 94033-088-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

• Height: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376116587 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183705

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: 2020-07-01
• Device Publish Date: 2020-06-23

On-Brand Devices [ATEC Porous Ti]

• 00190376102962: PS, 10 x 9 x 25 mm - 15°
• 00190376102955: PS, 8 x 9 x 25 mm - 15°
• 00190376102948: PS, 7 x 9 x 25 mm - 15°
• 00190376102931: PS, 12 x 9 x 25 mm - 10°
• 00190376102924: PS, 10 x 9 x 25 mm - 10°
• 00190376102917: PS, 9 x 9 x 25 mm - 10°
• 00190376102900: PS, 8 x 9 x 25 mm - 10°
• 00190376102894: PS, 7 x 9 x 25 mm - 10°
• 00190376191836: ATEC POROUS Ti, PS, 5DEG, 9WIDE, 25L x 12P x 13A
• 00190376185873: ATEC POROUS Ti, PS, 10DEG, 9WIDE, 25L x 10P x 12A
• 00190376185859: ATEC POROUS Ti, PS, 5DEG, 9WIDE, 25L x 10P x 11A
• 00190376185842: ATEC POROUS Ti, PS, 5DEG, 9WIDE, 25L x 8P x 9A
• 00190376185835: ATEC POROUS Ti, PS, 5DEG, 9WIDE, 25L x 7P x 8A
• 00190376116655: ATEC POROUS Ti, PC, 15DEG, 10WIDE, 30L x 9P x 12A
• 00190376116648: ATEC POROUS Ti, PC, 15DEG, 10WIDE, 30L x 7P x 10A
• 00190376116631: ATEC POROUS Ti, PC, 10DEG, 10WIDE, 30L x 10P x 12A
• 00190376116624: ATEC POROUS Ti, PC, 10DEG, 10WIDE, 30L x 9P x 11A
• 00190376116600: ATEC POROUS Ti, PC, 10DEG, 10WIDE, 30L x 7P x 9A
• 00190376116594: ATEC POROUS Ti, PC, 5DEG, 10WIDE, 30L x 11P x 12A
• 00190376116587: ATEC POROUS Ti, PC, 5DEG, 10WIDE, 30L x 10P x 11A
• 00190376116570: ATEC POROUS Ti, PC, 5DEG, 10WIDE, 30L x 9P x 10A
• 00190376276236: PTi PLIF Alpha Instruments
• 00190376276212: PTI TLIF-PC ALPHA INSTRUMENTS
• 00190376276205: PTI CERVICAL ALPHA INSTRUMENTS