Collage Osteoconductive Scaffold - Putty 710010

GUDID M2697100101

The Orthofix Collage Osteoconductive Scaffold - Putty (Orthofix Collage Putty) is a resorbable bone void filler made from a porous highly purified collagen matrix that has high purity tricalcium phosphate (TCP) granules dispersed throughout. The implant is provided sterile, nonpyrogenic, for single use in double peel packages. The Orthofix Collage Putty bone grafting construct is designed to facilitate the repair of bony defects. In the dry state, the matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. The Orthofix Collage Putty quickly imbibes fluids, making it easy to combine with bone marrow aspirate. The Orthofix Collage Putty guides the regeneration of bone across the defect site into which the Putty is implanted. New bone forms in apposition to the matrix surface when the graft is placed in direct contact with viable host bone. Ultimately the matrix is resorbed and remodeled into bone.

Integra Lifesciences Corporation

Bone matrix implant, composite

• Primary Device ID: M2697100101
• NIH Device Record Key: 74bd609d-981e-44f5-ad63-c4bbd42b3759
• Commercial Distribution Discontinuation: 2015-10-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Collage Osteoconductive Scaffold - Putty
• Version Model Number: 710010
• Catalog Number: 710010
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780114345 [Primary]
HIBCC	M2697100101 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062353

FDA Product Code

• MQV: FILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-22
• Device Publish Date: 2015-09-22

On-Brand Devices [Collage Osteoconductive Scaffold - Putty]

• 10381780112068: The Orthofix Collage Osteoconductive Scaffold - Putty (Orthofix Collage Putty) is a resorbable b
• 10381780112051: The Orthofix Collage Osteoconductive Scaffold - Putty (Orthofix Collage Putty) is a resorbable b
• 10381780112044: The Orthofix Collage Osteoconductive Scaffold - Putty (Orthofix Collage Putty) is a resorbable b
• M2697100151: The Orthofix Collage Osteoconductive Scaffold - Putty (Orthofix Collage Putty) is a resorbable b
• M2697100101: The Orthofix Collage Osteoconductive Scaffold - Putty (Orthofix Collage Putty) is a resorbable b
• M2697100051: The Orthofix Collage Osteoconductive Scaffold - Putty (Orthofix Collage Putty) is a resorbable b