ShurFit Interbody Deviceem 26-221000-12

GUDID 00840019910224

Wide PLIF Cage Peek 0 degree 22 x 10 X 12

PRECISION SPINE, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840019910224
• NIH Device Record Key: 19fe4176-f7bf-4e07-934f-31a64157adde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ShurFit Interbody Deviceem
• Version Model Number: 26-221000-12
• Catalog Number: 26-221000-12
• 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	00840019910224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092193

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00840019910224]

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: 2019-04-23

Devices Manufactured by PRECISION SPINE, INC.

• 00840019933612 - Reform Ti Modular: 2024-06-19 Ø6.5 x 40mm Modular Bone Screw, Cannulated
• 00840019938433 - Reform Ti Modular: 2024-05-29 Ø5.5mm Parallel Domino, Closed - Closed, Small
• 00840019938440 - Reform Ti Modular: 2024-05-29 Ø5.5mm Parallel Domino, Closed - Closed, Medium
• 00840019938457 - Reform Ti Modular: 2024-05-29 Ø5.5mm Parallel Domino, Closed - Closed, Large
• 00840019938464 - Reform Ti Modular: 2024-05-29 Ø5.5mm Parallel Domino, Closed - Closed, X-Large
• 00840019938471 - Reform Ti Modular: 2024-05-29 Ø5.5mm Parallel Domino, Closed - Top Load, Small
• 00840019938488 - Reform Ti Modular: 2024-05-29 Ø5.5mm Parallel Domino, Closed - Top Load, Medium
• 00840019938495 - Reform Ti Modular: 2024-05-29 Ø5.5mm Parallel Domino, Closed - Top Load, Large