ShurFit Lumbar Interbody 72-OPA-3612

GUDID 00840019952088

36 x 12mm 0° Oblique PEEK Interbody

PRECISION SPINE, INC.

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• Primary Device ID: 00840019952088
• NIH Device Record Key: b6b42993-648c-45de-b0de-fc4f71eb3363
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ShurFit Lumbar Interbody
• Version Model Number: 72-OPA-3612
• Catalog Number: 72-OPA-3612
• 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	00840019952088 [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

[00840019952088]

Moist Heat or Steam Sterilization

[00840019952088]

Moist Heat or Steam Sterilization

[00840019952088]

Moist Heat or Steam Sterilization

[00840019952088]

Moist Heat or Steam Sterilization

[00840019952088]

Moist Heat or Steam Sterilization

[00840019952088]

Moist Heat or Steam Sterilization

[00840019952088]

Moist Heat or Steam Sterilization

[00840019952088]

Moist Heat or Steam Sterilization

[00840019952088]

Moist Heat or Steam Sterilization

[00840019952088]

Moist Heat or Steam Sterilization

[00840019952088]

Moist Heat or Steam Sterilization

[00840019952088]

Moist Heat or Steam Sterilization

[00840019952088]

Moist Heat or Steam Sterilization

[00840019952088]

Moist Heat or Steam Sterilization

[00840019952088]

Moist Heat or Steam Sterilization

[00840019952088]

Moist Heat or Steam Sterilization

[00840019952088]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-23
• Device Publish Date: 2023-03-15

On-Brand Devices [ShurFit Lumbar Interbody]

• 00840019943543: 28 x 13mm 6° Curved 3D Ti Interbody
• 00840019943536: 28 x 12mm 6° Curved 3D Ti Interbody
• 00840019943529: 28 x 11mm 6° Curved 3D Ti Interbody
• 00840019943512: 28 x 10mm 6° Curved 3D Ti Interbody
• 00840019943505: 28 x 09mm 6° Curved 3D Ti Interbody
• 00840019943499: 28 x 08mm 6° Curved 3D Ti Interbody
• 00840019943482: 28 x 07mm 6° Curved 3D Ti Interbody
• 00840019943376: 28 x 06mm 0° Curved 3D Ti Interbody
• 00840019943260: 24 x 13mm 12° Curved 3D Ti Interbody
• 00840019943253: 24 x 12mm 12° Curved 3D Ti Interbody
• 00840019943246: 24 x 11mm 12° Curved 3D Ti Interbody
• 00840019943239: 24 x 10mm 12° Curved 3D Ti Interbody
• 00840019943222: 24 x 09mm 12° Curved 3D Ti Interbody
• 00840019943215: 24 x 08mm 12° Curved 3D Ti Interbody
• 00840019943185: 24 x 14mm 6° Curved 3D Ti Interbody
• 00840019943178: 24 x 13mm 6° Curved 3D Ti Interbody
• 00840019943161: 24 x 12mm 6° Curved 3D Ti Interbody
• 00840019943154: 24 x 11mm 6° Curved 3D Ti Interbody
• 00840019943147: 24 x 10mm 6° Curved 3D Ti Interbody
• 00840019943130: 24 x 09mm 6° Curved 3D Ti Interbody
• 00840019943123: 24 x 08mm 6° Curved 3D Ti Interbody
• 00840019943116: 24 x 07mm 6° Curved 3D Ti Interbody
• 00840019943000: 24 x 06mm 0° Curved 3D Ti Interbody
• 00840019944489: 22 x 06mm 0° Straight 3D Ti Interbody
• 00840019944014: 32 x 14mm 12° Curved 3D Ti Interbody
• 00840019944007: 32 x 13mm 12° Curved 3D Ti Interbody
• 00840019943994: 32 x 12mm 12° Curved 3D Ti Interbody
• 00840019943987: 32 x 11mm 12° Curved 3D Ti Interbody
• 00840019943970: 32 x 10mm 12° Curved 3D Ti Interbody
• 00840019943963: 32 x 09mm 12° Curved 3D Ti Interbody
• 00840019943956: 32 x 08mm 12° Curved 3D Ti Interbody
• 00840019943925: 32 x 14mm 6° Curved 3D Ti Interbody
• 00840019943918: 32 x 13mm 6° Curved 3D Ti Interbody
• 00840019943901: 32 x 12mm 6° Curved 3D Ti Interbody
• 00840019943895: 32 x 11mm 6° Curved 3D Ti Interbody
• 00840019943888: 32 x 10mm 6° Curved 3D Ti Interbody
• 00840019943871: 32 x 09mm 6° Curved 3D Ti Interbody
• 00840019943864: 32 x 08mm 6° Curved 3D Ti Interbody
• 00840019943857: 32 x 07mm 6° Curved 3D Ti Interbody
• 00840019943741: 32 x 06mm 0° Curved 3D Ti Interbody
• 00840019943642: 28 x 14mm 12° Curved 3D Ti Interbody
• 00840019943635: 28 x 13mm 12° Curved 3D Ti Interbody
• 00840019943628: 28 x 12mm 12° Curved 3D Ti Interbody
• 00840019943604: 28 x 10mm 12° Curved 3D Ti Interbody
• 00840019943598: 28 x 09mm 12° Curved 3D Ti Interbody
• 00840019943581: 28 x 08mm 12° Curved 3D Ti Interbody
• 00840019943550: 28 x 14mm 6° Curved 3D Ti Interbody
• 00840019944656: 22 x 14mm 6° Straight 3D Ti Interbody
• 00840019944649: 22 x 13mm 6° Straight 3D Ti Interbody
• 00840019944632: 22 x 12mm 6° Straight 3D Ti Interbody