INTERBODY FUSION ALIF0826-13P

GUDID 00815362023099

ALIF CAGE 8 DEG - 13MM (QTY 37)

PRECISION SPINE, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00815362023099
• NIH Device Record Key: c1d63a7f-0b22-4d11-972e-cb14c32d8077
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTERBODY FUSION
• Version Model Number: 5119PM
• Catalog Number: ALIF0826-13P
• Company DUNS: 079398589
• Company Name: PRECISION SPINE, INC.
• Device Count: 1
• DM Exempt: false
• 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: 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	00815362023099 [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

[00815362023099]

Moist Heat or Steam Sterilization

[00815362023099]

Moist Heat or Steam Sterilization

[00815362023099]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-12-05

On-Brand Devices [INTERBODY FUSION ]

• 00815362023242: SHURFIT LLIF PEEK 22x60x14mm (qty 13)
• 00815362023211: ALIF CAGE 15DEG- 19MM (QTY 21)
• 00815362023204: ALIF CAGE 15DEG - 19MM (QTY 29)
• 00815362023198: ALIF CAGE 15DEG - 17MM (QTY 25)
• 00815362023181: ALIF CAGE 15DEG - 15MM (QTY 14)
• 00815362023174: ALIF CAGE 15DEG- 13MM (QTY 18)
• 00815362023167: ALIF CAGE 15 degree-11MM (QTY 27)
• 00815362023150: ALIF CAGE 8 DEG - 19MM (QTY 35)
• 00815362023143: ALIF CAGE 8 DEG - 17MM (QTY 31 )
• 00815362023136: ALIF CAGE 8 DEG - 17MM (QTY 28 )
• 00815362023129: ALIF CAGE 8DEG - 15MM (QTY 58 )
• 00815362023112: ALIF CAGE 8 DEG - 15MM (QTY 31 )
• 00815362023105: ALIF CAGE 8 DEG - 15MM (QTY 29 )
• 00815362023099: ALIF CAGE 8 DEG - 13MM (QTY 37)
• 00815362023082: ALIF CAGE 8 DEG - 11MM (QTY 27 )
• 00815362023075: ALIF CAGE 8 DEG- 11MM (QTY 31 )
• 00815362023068: ALIF CAGE 8 DEG - 9MM (QTY 39 )
• 00815362023051: ALIF CAGE 8 deg - 9mm (QTY 27)
• 00815362023044: ALIF CAGE 8 deg - 9mm (QTY 29)
• 00815362023037: ALIF CAGE 8 DEG- 15MM (QTY 223)
• 00815362023020: ALIF CAGE 8 DEG-11MM (QTY 70)