ShurFit Interbody Device 68-SC-0200

GUDID 00840019935623

TLIF/PLIF/TPLIF Instrument Case

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00840019935623
• NIH Device Record Key: 2ece6d33-8ec5-47b4-92a4-e2e3fb062dc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ShurFit Interbody Device
• Version Model Number: 68-SC-0200
• Catalog Number: 68-SC-0200
• 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: false
• 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	00840019935623 [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

[00840019935623]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-11
• Device Publish Date: 2019-09-03

On-Brand Devices [ShurFit Interbody Device]

• 00840019930819: TLIF Sizer 7mm x 24mm
• 00840019930864: TLIF Sizer 11mm x 30mm
• 00840019930833: TLIF Sizer 11mm x 24mm
• 00840019930826: TLIF Sizer 9mm x 24mm
• 00840019909969: TLIF Cage Peek 16mm x 30mm
• 00840019909952: TLIF Cage Peek 14mm x 30mm
• 00840019909945: TLIF Cage Peek 12mm x 30mm
• 00840019909938: TLIF Cage Peek 11mm x 30mm
• 00840019909921: TLIF Cage Peek 10mm x 30mm
• 00840019909914: TLIF Cage Peek 9mm x 30mm
• 00840019909907: TLIF Cage Peek 8mm x 30mm
• 00840019909891: TLIF Cage Peek 7mm x 30mm
• 00840019909884: TLIF Cage Peek 6mm x 30mm
• 00840019909877: TLIF Cage Peek 16mm x 24mm
• 00840019909860: TLIF Cage Peek 14mm x 24mm
• 00840019909853: TLIF Cage Peek 12mm x 24mm
• 00840019909846: TLIF Cage Peek 11mm x 24mm
• 00840019909839: TLIF Cage Peek 10mm x 24mm
• 00840019909822: TLIF Cage Peek 9mm x 24mm
• 00840019909815: TLIF Cage Peek 8mm x 24mm
• 00840019909808: TLIF Cage Peek 7mm x 24mm
• 00840019909792: TLIF Cage Peek 6mm x 24mm
• 00840019909785: PLIF Cage Peek, 16mm x 25mm
• 00840019909778: PLIF Cage Peek, 15mm x 25mm
• 00840019909761: PLIF Cage Peek, 14mm x 25mm
• 00840019909754: PLIF Cage Peek, 13mm x 25mm
• 00840019909747: PLIF Cage Peek, 12mm x 25mm
• 00840019909730: PLIF Cage Peek, 11mm x 25mm
• 00840019909723: PLIF Cage Peek, 10mm x 25mm
• 00840019909716: PLIF Cage Peek, 9mm x 25mm
• 00840019909709: PLIF Cage Peek, 8mm x 25mm
• 00840019909693: PLIF Cage Peek 16mm x 22mm
• 00840019909686: PLIF Cage Peek 15mm x 22mm
• 00840019909679: PLIF Cage Peek 14mm x 22mm
• 00840019909662: PLIF Cage Peek 13mm x 22mm
• 00840019909655: PLIF Cage Peek 12mm x 22mm
• 00840019909648: PLIF Cage Peek 11mm x 22mm
• 00840019909631: PLIF Cage Peek 10mm x 22mm
• 00840019909624: PLIF Cage Peek 9mm x 22mm
• 00840019909617: PLIF Cage Peek, 8mm x 22mm
• 00840019930895: TPLIF Convex Caddy
• 00840019930888: TLIF Caddy
• 00840019930871: PLIF Caddy
• 00840019930857: TLIF Sizer 9mm x 30mm
• 00840019930840: TLIF Sizer 7mm x 30mm
• 00840019923644: 15mm PLIF 15 degree Paddle Shaver
• 00840019910743: 30 x 14mm 15 degree O TPLIF
• 00840019910736: 30 x 12mm 15 degree O TPLIF
• 00840019910729: 30 x 10mm 15 degree O TPLIF
• 00840019910712: 30 x 14mm 10 degree O TPLIF