ShurFit® LLIF System 23-EC2455-16

GUDID 00840019966061

24x55x16mm - 7° PEEK Cage

PRECISION SPINE, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840019966061
• NIH Device Record Key: 78084077-5948-4cff-8d33-c706e16934da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ShurFit® LLIF System
• Version Model Number: 23-EC2455-16
• Catalog Number: 23-EC2455-16
• 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	00840019966061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092193

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00840019966061]

Moist Heat or Steam Sterilization

[00840019966061]

Moist Heat or Steam Sterilization

[00840019966061]

Moist Heat or Steam Sterilization

[00840019966061]

Moist Heat or Steam Sterilization

[00840019966061]

Moist Heat or Steam Sterilization

[00840019966061]

Moist Heat or Steam Sterilization

[00840019966061]

Moist Heat or Steam Sterilization

[00840019966061]

Moist Heat or Steam Sterilization

[00840019966061]

Moist Heat or Steam Sterilization

[00840019966061]

Moist Heat or Steam Sterilization

[00840019966061]

Moist Heat or Steam Sterilization

[00840019966061]

Moist Heat or Steam Sterilization

[00840019966061]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-24
• Device Publish Date: 2022-08-16

On-Brand Devices [ShurFit® LLIF System]

• 00840019966085: 24x60x10mm - 7° PEEK Cage
• 00840019966078: 24x60x08mm - 7° PEEK Cage
• 00840019966061: 24x55x16mm - 7° PEEK Cage
• 00840019966054: 24x55x14mm - 7° PEEK Cage
• 00840019966047: 24x55x12mm - 7° PEEK Cage
• 00840019966030: 24x55x10mm - 7° PEEK Cage
• 00840019966023: 24x55x08mm - 7° PEEK Cage
• 00840019966016: 24x50x16mm - 7° PEEK Cage
• 00840019966009: 24x50x14mm - 7° PEEK Cage
• 00840019965996: 24x50x12mm - 7° PEEK Cage
• 00840019965989: 24x50x10mm - 7° PEEK Cage
• 00840019965972: 24x50x08mm - 7° PEEK Cage
• 00840019965965: 24x45x16mm - 7° PEEK Cage
• 00840019965958: 24x45x14mm - 7° PEEK Cage
• 00840019965941: 24x45x12mm - 7° PEEK Cage
• 00840019965934: 24x45x10mm - 7° PEEK Cage
• 00840019966696: 22x60x14mm - 15° PEEK Cage
• 00840019966689: 22x60x12mm - 15° PEEK Cage
• 00840019966672: 22x60x10mm - 15° PEEK Cage
• 00840019966665: 22x55x18mm - 15° PEEK Cage
• 00840019966658: 22x55x16mm - 15° PEEK Cage
• 00840019966641: 22x55x14mm - 15° PEEK Cage
• 00840019966634: 22x55x12mm - 15° PEEK Cage
• 00840019966627: 22x55x10mm - 15° PEEK Cage
• 00840019966610: 22x50x18mm - 15° PEEK Cage
• 00840019966603: 22x50x16mm - 15° PEEK Cage
• 00840019966597: 22x50x14mm - 15° PEEK Cage
• 00840019966580: 22x50x12mm - 15° PEEK Cage
• 00840019966573: 22x50x10mm - 15° PEEK Cage
• 00840019966566: 22x45x18mm - 15° PEEK Cage
• 00840019966559: 22x45x16mm - 15° PEEK Cage
• 00840019966542: 22x45x14mm - 15° PEEK Cage
• 00840019966535: 22x45x12mm - 15° PEEK Cage
• 00840019966528: 22x45x10mm - 15° PEEK Cage
• 00840019966511: 18x60x18mm - 15° PEEK Cage
• 00840019966504: 18x60x16mm - 15° PEEK Cage
• 00840019966498: 18x60x14mm - 15° PEEK Cage
• 00840019966481: 18x60x12mm - 15° PEEK Cage
• 00840019966474: 18x60x10mm - 15° PEEK Cage
• 00840019966467: 18x55x18mm - 15° PEEK Cage
• 00840019966450: 18x55x16mm - 15° PEEK Cage
• 00840019966443: 18x55x14mm - 15° PEEK Cage
• 00840019966436: 18x55x12mm - 15° PEEK Cage
• 00840019966429: 18x55x10mm - 15° PEEK Cage
• 00840019966412: 18x50x18mm - 15° PEEK Cage
• 00840019966405: 18x50x16mm - 15° PEEK Cage
• 00840019966399: 18x50x14mm - 15° PEEK Cage
• 00840019966382: 18x50x12mm - 15° PEEK Cage
• 00840019966375: 18x50x10mm - 15° PEEK Cage
• 00840019966368: 18x45x18mm - 15° PEEK Cage