L-Varlock VAL-CA-13-08

GUDID 00850011324004

The L-Varlock is a lumbar cage, for intervertebral body fusion.

SPINESOURCE INC

Metallic spinal fusion cage, non-sterile

• Primary Device ID: 00850011324004
• NIH Device Record Key: cff691c9-261f-4432-8d0e-cb9ff7d917aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L-Varlock
• Version Model Number: 004
• Catalog Number: VAL-CA-13-08
• Company DUNS: 150955560
• Company Name: SPINESOURCE 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

Device Dimensions

• Height: 8 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *store away from light and sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011324004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080537

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00850011324004]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-23
• Device Publish Date: 2019-08-15

On-Brand Devices [L-Varlock]

• 00850011324103: Instrument, Slap Hammer Adapter
• 00850011324097: Instrument, Expansion Screwdriver, Long
• 00850011324110: The L-Varlock is a lumbar cage, for intervertebral body fusion.
• 00850011324127: Instrument, Implant Stabilizer
• 00850011324080: Instrument, Disc Shaver, 13mm
• 00850011324073: Instrument, Disc Shaver, 12mm
• 00850011324066: Instrument, Disc Shaver, 11mm
• 00850011324059: Instrument, Disc Shaver, 10mm
• 00850011324042: Instrument, Disc Shaver, 9mm
• 00850011324035: Instrument, Disc Shaver, 8mm
• 00850011324028: Instrument, Disc Shaver, 7mm
• 00850011324011: Instrument, Implant Stabilizer
• 00850011324004: The L-Varlock is a lumbar cage, for intervertebral body fusion.
• 00850011324134: The L-Varlock is a lumbar cage, for intervertebral body fusion.
• 00850011324141: Instrument, Inserter
• 00850011324165: The L-Varlock is a lumbar cage, for intervertebral body fusion.
• 00850011324158: The L-Varlock is a lumbar cage, for intervertebral body fusion.