ShurFit PLIF Titanium PLIF22-12

GUDID 00840019929325

PLIF Cage 12mm x 22mm

PRECISION SPINE, INC.

Metallic spinal fusion cage, non-sterile

• Primary Device ID: 00840019929325
• NIH Device Record Key: 2ca7bcc6-62b0-4aad-bce8-1ea3abdbf224
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ShurFit PLIF Titanium
• Version Model Number: PLIF22-12
• Catalog Number: PLIF22-12
• 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	00840019929325 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080314

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00840019929325]

Moist Heat or Steam Sterilization

[00840019929325]

Moist Heat or Steam Sterilization

[00840019929325]

Moist Heat or Steam Sterilization

[00840019929325]

Moist Heat or Steam Sterilization

[00840019929325]

Moist Heat or Steam Sterilization

[00840019929325]

Moist Heat or Steam Sterilization

[00840019929325]

Moist Heat or Steam Sterilization

[00840019929325]

Moist Heat or Steam Sterilization

[00840019929325]

Moist Heat or Steam Sterilization

[00840019929325]

Moist Heat or Steam Sterilization

[00840019929325]

Moist Heat or Steam Sterilization

[00840019929325]

Moist Heat or Steam Sterilization

[00840019929325]

Moist Heat or Steam Sterilization

[00840019929325]

Moist Heat or Steam Sterilization

[00840019929325]

Moist Heat or Steam Sterilization

[00840019929325]

Moist Heat or Steam Sterilization

[00840019929325]

Moist Heat or Steam Sterilization

[00840019929325]

Moist Heat or Steam Sterilization

[00840019929325]

Moist Heat or Steam Sterilization

[00840019929325]

Moist Heat or Steam Sterilization

[00840019929325]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-04
• Device Publish Date: 2019-03-27

On-Brand Devices [ShurFit PLIF Titanium ]

• 00840019929455: PLIF Cage, 16mm x 25mm
• 00840019929431: PLIF Cage, 14mm x 25mm
• 00840019929424: PLIF Cage, 13mm x 25mm
• 00840019929417: PLIF Cage, 12mm x 25mm
• 00840019929400: PLIF Cage, 11mm x 25mm
• 00840019929394: PLIF25-10
• 00840019929387: PLIF Cage 9mm x 25mm
• 00840019929370: PLIF Cage, 8mm x 25mm
• 00840019929363: PLIF Cage 16mm x 22mm
• 00840019929356: PLIF Cage 15mm x 22mm
• 00840019929349: PLIF Cage 14mm x 22mm
• 00840019929332: PLIF Cage 13mm x 22mm
• 00840019929325: PLIF Cage 12mm x 22mm
• 00840019929318: PLIF Cage 11mm x 22mm
• 00840019929301: PLIF Cage 10mm x 22mm
• 00840019929288: PLIF Cage 8mm x 22mm
• 00840019929448: PLIF Cage, 15mm x 25mm
• 00840019929295: PLIF Cage 9mm x 22mm