X-Pac SV2461

GUDID 00853954003319

Spine View 9mm Cage Trial

SPINE VIEW, INC.

Metallic spinal fusion cage, non-sterile

• Primary Device ID: 00853954003319
• NIH Device Record Key: 05d6e0db-5b0a-4fc8-ad75-95442eacc617
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-Pac
• Version Model Number: SV2461
• Catalog Number: SV2461
• Company DUNS: 787239057
• Company Name: SPINE VIEW, 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: 5107435090
• Email: mmuthini@spineview.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853954003319 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152539

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00853954003319]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [X-Pac]

• 00853954003340: Spine View Cage Delivery Case
• 00853954003333: Spine View Cage Delivery Case
• 00853954003326: Spine View 12mm Cage Trial
• 00853954003319: Spine View 9mm Cage Trial
• 00853954003302: Spine View 7mm Cage Trial
• 00853954003296: Spine View 8mm Distraction Tool
• 00853954003289: Spine View Bone Packing Bowl
• 00853954003272: Spine View Bone Bone Plunger
• 00853954003265: Spine View Bone Bone Compactor
• 00853954003258: Spine View Bone Funnel
• 00853954003241: Spine View Cage Extraction Tool
• 00853954003234: Spine View Cage Cannula
• 00853954003227: Spine View Cage Insertion tool
• 00853954003210: Spine View Expandable Lumbar Cage, 32mm Lordotic
• 00853954003203: Spine View Expandable Lumbar Cage, 32mm Parallel
• 00853954003197: Spine View Expandable Lumbar Cage, 28mm Parallel
• 00853954003180: Spine View Expandable Lumbar Cage, 28mm Lordotic