OPTEFORM® Allograft Partial Disc, 90mm x 5mm, 22cc 602-05-90

GUDID 10885862094100

Surgalign Spine Technologies, Inc.

Bone matrix implant, human-derived

• Primary Device ID: 10885862094100
• NIH Device Record Key: eef15fdc-72ff-4e26-b975-d507d943191a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTEFORM® Allograft Partial Disc, 90mm x 5mm, 22cc
• Version Model Number: 002590
• Catalog Number: 602-05-90
• Company DUNS: 014520584
• Company Name: Surgalign Spine Technologies, 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: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862094100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043421

FDA Product Code

• MQV: FILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-05
• Device Publish Date: 2015-11-06

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