OPTEFORM® Allograft Paste, 20cc 606-01-20

GUDID 10885862094254

Surgalign Spine Technologies, Inc.

Bone matrix implant, human-derived

• Primary Device ID: 10885862094254
• NIH Device Record Key: da489fe7-206d-4664-be82-0f62310a0c65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTEFORM® Allograft Paste, 20cc
• Version Model Number: 005120
• Catalog Number: 606-01-20
• 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 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862094254 [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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• 00840311236923 - Streamline OCT: 2023-10-13 Ø3.2mm x 100mm CoCr Rod
• 00840311236930 - Streamline OCT: 2023-10-13 Ø3.2mm x 110mm CoCr Rod
• 00840311236947 - Streamline OCT: 2023-10-13 Ø3.2mm x 120mm CoCr Rod
• 00840311236954 - Streamline OCT: 2023-10-13 Ø3.2mm x 160mm CoCr Rod
• 00840311236961 - Streamline OCT: 2023-10-13 Ø3.2mm x 180mm CoCr Rod
• 00840311236978 - Streamline OCT: 2023-10-13 Ø3.2mm x 20mm CoCr Rod