IMPIX-TLIF B15130617S

GUDID 03613720267102

IMPIX-TLIF LUMBAR CAGE 17mm - 6°

MEDICREA INTERNATIONAL

Polymeric spinal interbody fusion cage

• Primary Device ID: 03613720267102
• NIH Device Record Key: ccfdf3d9-bf9d-45df-a081-7d32b7d71386
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPIX-TLIF
• Version Model Number: B15130617S
• Catalog Number: B15130617S
• Company DUNS: 383228632
• Company Name: MEDICREA INTERNATIONAL
• 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: true
• 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	03613720267102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083798

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-08-07
• Device Publish Date: 2019-01-11

On-Brand Devices [IMPIX-TLIF]

• 03613720217503: IMPIX-TLIF THREADED ROD v2
• 03613720217497: IMPIX-TLIF HOLDER v2
• 03613720217442: ANTI-ROTATION IMPIX-TLIF HOLDER
• 03613720217435: IMPIX-TLIF HOLDER STD
• 03613720217428: IMPIX-TLIF HOLDER STD THREADED ROD
• 03613720217312: IMPIX-TLIF HOLDER THREADED ROD
• 03613720217305: IMPIX-TLIF HOLDER
• 03613720267102: IMPIX-TLIF LUMBAR CAGE 17mm - 6°
• 03613720217534: TRIAL FOR IMPIX-TLIF 11mm - 6°
• 03613720217480: STRAIGHT HANDLE WITH HAMMERING PLATE
• 03613720217374: LEFT VALVE FOR LAMINA
• 03613720217367: TLIF DISTRACTOR
• 03613720217350: RIGHT VALVE ON SCREWS
• 03613720217558: TRIAL FOR IMPIX-TLIF 15mm - 6°
• 03613720217541: TRIAL FOR IMPIX-TLIF 13mm - 6°
• 03613720217527: TRIAL FOR IMPIX-TLIF 9mm - 6°
• 03613720217510: TRIAL FOR IMPIX-TLIF 7mm - 6°
• 03613720217466: LARGE VALVE RETRACTOR
• 03613720217459: SMALL VALVE RETRACTOR
• 03613720217404: SUPPORT LID
• 03613720217398: STRAIGHT HANDLE WITH HAMMERING PLATE
• 03613720217381: RIGHT VALVE FOR LAMINA
• 03613720217343: LEFT VALVE ON SCREWS
• 03613720217336: IMPIX-TLIF GRAFT COMPACTOR
• 03613720217329: IMPIX-TLIF SUPPORT
• 03613720217299: IMPIX-TLIF INSTRUMENT CASE