s 72-OPA-3606-2C

GUDID 00840019956673

36 x 06mm 0° Oblique PEEK 2C Interbody

PRECISION SPINE, INC.

Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 00840019956673
• NIH Device Record Key: ca038920-7b0b-46d7-8351-1dd1fb9bea07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s
• Version Model Number: 72-OPA-3606-2C
• Catalog Number: 72-OPA-3606-2C
• Company DUNS: 079398589
• Company Name: PRECISION SPINE, 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00840019956673 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212075

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00840019956673]

Moist Heat or Steam Sterilization

[00840019956673]

Moist Heat or Steam Sterilization

[00840019956673]

Moist Heat or Steam Sterilization

[00840019956673]

Moist Heat or Steam Sterilization

[00840019956673]

Moist Heat or Steam Sterilization

[00840019956673]

Moist Heat or Steam Sterilization

[00840019956673]

Moist Heat or Steam Sterilization

[00840019956673]

Moist Heat or Steam Sterilization

[00840019956673]

Moist Heat or Steam Sterilization

[00840019956673]

Moist Heat or Steam Sterilization

[00840019956673]

Moist Heat or Steam Sterilization

[00840019956673]

Moist Heat or Steam Sterilization

[00840019956673]

Moist Heat or Steam Sterilization

[00840019956673]

Moist Heat or Steam Sterilization

[00840019956673]

Moist Heat or Steam Sterilization

[00840019956673]

Moist Heat or Steam Sterilization

[00840019956673]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-06
• Device Publish Date: 2025-05-29

Devices Manufactured by PRECISION SPINE, INC.

• 00840019956567 - ShurFit Lumbar Interbody: 2025-06-06 32 x 11mm 12° Oblique PEEK 2C Interbody
• 00840019956574 - ShurFit Lumbar Interbody: 2025-06-06 32 x 12mm 12° Oblique PEEK 2C Interbody
• 00840019956581 - ShurFit Lumbar Interbody: 2025-06-06 32 x 13mm 12° Oblique PEEK 2C Interbody
• 00840019956598 - ShurFit Lumbar Interbody: 2025-06-06 32 x 14mm 12° Oblique PEEK 2C Interbody
• 00840019956604 - ShurFit Lumbar Interbody: 2025-06-06 32 x 15mm 12° Oblique PEEK 2C Interbody
• 00840019956611 - ShurFit Lumbar Interbody: 2025-06-06 32 x 16mm 12° Oblique PEEK 2C Interbody
• 00840019956628 - ShurFit Lumbar Interbody: 2025-06-06 32 x 12mm 16° Oblique PEEK 2C Interbody
• 00840019956635 - ShurFit Lumbar Interbody: 2025-06-06 32 x 13mm 16° Oblique PEEK 2C Interbody