ShurFit 2C Lumbar Interbody 23-PC2255-08-2C

GUDID 00840019930628

22x55x08mm - 0° PEEK 2C Cage

PRECISION SPINE, INC.

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• Primary Device ID: 00840019930628
• NIH Device Record Key: 2709a711-7067-48d9-aaa2-3027e45dc933
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ShurFit 2C Lumbar Interbody
• Version Model Number: 23-PC2255-08-2C
• Catalog Number: 23-PC2255-08-2C
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00840019930628 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171657

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00840019930628]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-03-28

On-Brand Devices [ShurFit 2C Lumbar Interbody ]

• 00840019930512: 18x60x16mm - 0° PEEK 2C Cage
• 00840019930710: 22x60x16mm - 0° PEEK 2C Cage
• 00840019930703: 22x60x14mm - 0° PEEK 2C Cage
• 00840019930697: 22x60x12mm - 0° PEEK 2C Cage
• 00840019930680: 22x60x10mm - 0° PEEK 2C Cage
• 00840019930673: 22x60x08mm - 0° PEEK 2C Cage
• 00840019930666: 22x55x16mm - 0° PEEK 2C Cage
• 00840019930659: 22x55x14mm - 0° PEEK 2C Cage
• 00840019930642: 22x55x12mm - 0° PEEK 2C Cage
• 00840019930635: 22x55x10mm - 0° PEEK 2C Cage
• 00840019930628: 22x55x08mm - 0° PEEK 2C Cage
• 00840019930611: 22x50x16mm - 0° PEEK 2C Cage
• 00840019930604: 22x50x14mm - 0° PEEK 2C Cage
• 00840019930581: 22x50x10mm - 0° PEEK 2C Cage
• 00840019930574: 22x50x08mm - 0° PEEK 2C Cage
• 00840019930567: 22x45x16mm - 0° PEEK 2C Cage
• 00840019930550: 22x45x14mm - 0° PEEK 2C Cage
• 00840019930543: 22x45x12mm - 0° PEEK 2C Cage
• 00840019930536: 22x45x10mm - 0° PEEK 2C Cage
• 00840019930529: 22x45x08mm - 0° PEEK 2C Cage
• 00840019930505: 18x60x14mm - 0° PEEK 2C Cage
• 00840019930499: 18x60x12mm - 0° PEEK 2C Cage
• 00840019930482: 18x60x10mm - 0° PEEK 2C Cage
• 00840019930475: 18x60x08mm - 0° PEEK 2C Cage
• 00840019930468: 18x55x16mm - 0° PEEK 2C Cage
• 00840019930451: 18x55x14mm - 0° PEEK 2C Cage
• 00840019930444: 18x55x12mm - 0° PEEK 2C Cage
• 00840019930437: 18x55x10mm - 0° PEEK 2C Cage
• 00840019930420: 18x55x08mm - 0° PEEK 2C Cage
• 00840019930413: 18x50x16mm - 0° PEEK 2C Cage
• 00840019930406: 18x50x14mm - 0° PEEK 2C Cage
• 00840019930390: 18x50x12mm - 0° PEEK 2C Cage
• 00840019930383: 18x50x10mm - 0° PEEK 2C Cage
• 00840019930376: 18x50x08mm - 0° PEEK 2C Cage
• 00840019930369: 18x45x16mm - 0° PEEK 2C Cage
• 00840019930352: 18x45x14mm - 0° PEEK 2C Cage
• 00840019930345: 18x45x12mm - 0° PEEK 2C Cage
• 00840019930338: 18x45x10mm - 0° PEEK 2C Cage
• 00840019930321: 18x45x08mm - 0° PEEK 2C Cage
• 00840019930314: 22x60x16mm - 7° PEEK 2C Cage
• 00840019930307: 22x60x14mm - 7° PEEK 2C Cage
• 00840019930291: 22x60x12mm - 7° PEEK 2C Cage
• 00840019930284: 22x60x10mm - 7° PEEK 2C Cage
• 00840019930277: 22x60x08mm - 7° PEEK 2C Cage
• 00840019930260: 22x55x16mm - 7° PEEK 2C Cage
• 00840019930253: 22x55x14mm - 7° PEEK 2C Cage
• 00840019930246: 22x55x12mm - 7° PEEK 2C Cage
• 00840019930239: 22x55x10mm - 7° PEEK 2C Cage
• 00840019930222: 22x55x08mm - 7° PEEK 2C Cage
• 00840019930215: 22x50x16mm - 7° PEEK 2C Cage