Collage

GUDID 18257200121878

Osteoconductive Scaffold Strip, 15cc

ORTHOFIX INC.

Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite

• Primary Device ID: 18257200121878
• NIH Device Record Key: c6bc4a79-1dc2-4c57-83df-20b7cda46c71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Collage
• Version Model Number: 711015
• Company DUNS: 927083808
• Company Name: ORTHOFIX 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: true
• 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(214)937-3199
• Email: osi-customerservice@orthofix.c
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.c
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200121878 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063124

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-14

On-Brand Devices [Collage ]

• 18257200121878: Osteoconductive Scaffold Strip, 15cc
• 18257200121861: Osteoconductive Scaffold Strip 10 cc
• 18257200115136: Collage Osteoconductive Scaffold Putty 15cc
• 18257200115129: Collage Osteoconductive Scaffold Putty 10 cc
• 18257200115112: Collage Osteoconductive Scaffold Putty, 5cc