Arena-L®

GUDID 00190361006053

Arena-L, 38x28, Lordotic 8 degrees, 16H

SPINEFRONTIER, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00190361006053
• NIH Device Record Key: 27a10cc8-7e5f-4259-a3c9-390a4e1c7814
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arena-L®
• Version Model Number: 01-81010-16
• Company DUNS: 002003243
• Company Name: SPINEFRONTIER, 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: 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(866)914-7717
• Email: customerservice@spinefrontier.com

Device Dimensions

• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190361006053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111553

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00190361006053]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-04-15

On-Brand Devices [Arena-L®]

• 00190361039358: 21X27 TRIAL HEAD, ARENA-L ALLO, 20MM
• 00190361039341: 21X27 TRIAL HEAD, ARENA-L ALLO, 18MM
• 00190361039334: 21X27 TRIAL HEAD, ARENA-L ALLO, 16MM
• 00190361039327: 21X27 TRIAL HEAD, ARENA-L ALLO, 14MM
• 00190361039310: 21X27 TRIAL HEAD, ARENA-L ALLO, 12MM
• 00190361039303: 21X27 TRIAL HEAD, ARENA-L ALLO, 10MM
• 00190361039297: 21X27 TRIAL HEAD, ARENA-L ALLO, 8MM
• 00190361039280: 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 20MM
• 00190361039273: 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 18MM
• 00190361039266: 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 16MM
• 00190361039259: 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 14MM
• 00190361039242: 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 12MM
• 00190361039235: 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 10MM
• 00190361039228: 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 8MM
• 00190361039211: 21X27 TRIAL HEAD, ARENA-L ALLO, 21MM
• 00190361039204: 21X27 TRIAL HEAD, ARENA-L ALLO, 19MM
• 00190361039198: 21X27 TRIAL HEAD, ARENA-L ALLO, 17MM
• 00190361039181: 21X27 TRIAL HEAD, ARENA-L ALLO, 15MM
• 00190361039174: 21X27 TRIAL HEAD, ARENA-L ALLO, 13MM
• 00190361039167: 21X27 TRIAL HEAD, ARENA-L ALLO, 11MM
• 00190361039150: 21X27 TRIAL HEAD, ARENA-L ALLO, 9MM
• 00190361039143: 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 21MM
• 00190361039136: 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 19MM
• 00190361039129: 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 17MM
• 00190361039112: 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 15MM
• 00190361039105: 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 13MM
• 00190361039099: 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 11MM
• 00190361039082: 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 9MM
• 00190361039075: 7MM 21X27 TRIAL, ARENA-L ALLO
• 00190361039068: 7MM 21X27 TRIAL RASP, ARENA-L ALLO
• 00190361039051: Rasp Trial Head, 38X28 Lordotic 12°, 17L
• 00190361039044: Rasp Trial Head, 38X28 Lordotic 12°, 15L
• 00190361039037: Rasp Trial Head, 38X28 Lordotic 12°, 13L
• 00190361039020: Rasp Trial Head, 38X28 Lordotic 12°, 11L
• 00190361039013: Rasp Trial Head, 35X26 Lordotic 12°, 17L
• 00190361039006: Rasp Trial Head, 35X26 Lordotic 12°, 15L
• 00190361038993: Rasp Trial Head, 35X26 Lordotic 12°, 13L
• 00190361038986: Rasp Trial Head, 35X26 Lordotic 12°, 11L
• 00190361038979: Rasp Trial Head, 38X28 Lordotic 8°, 17L
• 00190361038962: Rasp Trial Head, 38X28 Lordotic 8°, 15L
• 00190361038955: Rasp Trial Head, 38X28 Lordotic 8°, 13L
• 00190361038948: Rasp Trial Head, 38X28 Lordotic 8°, 11L
• 00190361038931: Rasp Trial Head, 38X28 Lordotic 8°, 9L
• 00190361038924: Flat Trial Head, 38X28 Lordotic 8°, 19L
• 00190361038917: Flat Trial Head, 38X28 Lordotic 8°, 17L
• 00190361038900: Flat Trial Head, 38X28 Lordotic 8°, 15L
• 00190361038894: Flat Trial Head, 38X28 Lordotic 8°, 13L
• 00190361038887: Flat Trial Head, 38X28 Lordotic 8°, 11L
• 00190361038870: Flat Trial Head, 38X28 Lordotic 8°, 9L
• 00190361038863: Rasp Trial Head, 35X26 Lordotic 8° 17L