ostaPek Interbody Fusion Cage

GUDID 07640173167495

gemitra ipsi wide

coLigne AG

Polymeric spinal interbody fusion cage

• Primary Device ID: 07640173167495
• NIH Device Record Key: f51ebd60-f76d-4adb-8a84-ae7237711e0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ostaPek Interbody Fusion Cage
• Version Model Number: 29.124
• Company DUNS: 482467792
• Company Name: coLigne AG
• 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

Customer Support Contacts

• Phone: +41433438000
• Email: info@coligne.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640173167495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181963

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[07640173167495]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-08-08

On-Brand Devices [ostaPek Interbody Fusion Cage]

• 07640173168690: Anterior
• 07640173168683: Anterior
• 07640173168676: Anterior
• 07640173168669: ALIF wilhelm tell
• 07640173168652: ALIF wilhelm tell
• 07640173168645: ALIF wilhelm tell
• 07640173168638: ALIF wilhelm tell
• 07640173168621: ALIF wilhelm tell
• 07640173168614: ALIF wilhelm tell
• 07640173168607: ALIF wilhelm tell
• 07640173168591: ALIF wilhelm tell
• 07640173168584: ALIF wilhelm tell
• 07640173168577: ALIF wilhelm tell
• 07640173168560: ALIF wilhelm tell
• 07640173168553: ALIF wilhelm tell
• 07640173168546: ALIF wilhelm tell
• 07640173168539: ALIF wilhelm tell
• 07640173168522: ALIF small
• 07640173168515: ALIF small
• 07640173168508: ALIF small
• 07640173168492: ALIF small
• 07640173168485: ALIF small
• 07640173168478: ALIF small
• 07640173168461: ALIF small
• 07640173168454: ALIF
• 07640173168447: ALIF
• 07640173168430: ALIF
• 07640173168423: ALIF
• 07640173168416: ALIF
• 07640173168409: ALIF
• 07640173168393: ALIF
• 07640173168386: ALIF
• 07640173168379: Bullet
• 07640173168362: Bullet
• 07640173168355: Bullet
• 07640173168348: Bullet
• 07640173168331: Bullet
• 07640173168324: Bullet
• 07640173168317: PLIF bullet true
• 07640173168300: PLIF bullet true
• 07640173168294: PLIF bullet true
• 07640173168287: PLIF bullet true
• 07640173168270: PLIF bullet true
• 07640173168263: PLIF bullet true
• 07640173168256: PLIF bullet true
• 07640173168249: PLIF bullet true
• 07640173168232: PLIF bullet true
• 07640173168225: PLIF bullet true
• 07640173168218: PLIF bullet true
• 07640173168201: PLIF bullet true