IsoTis Mozaik Strip CCM10256

GUDID M386CCM102561

IsoTis Mozaik™ Strip, 15cc - a resorbable bone void filler made from a bovine collagen matrix that has tricalcium phosphate (TCP) granules dispersed t

ISOTIS ORTHOBIOLOGICS, 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 Bone matrix implant, composite Bone matrix implant, composite

• Primary Device ID: M386CCM102561
• NIH Device Record Key: 57e9b1bf-4465-424d-a308-fbbb85cef409
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IsoTis Mozaik Strip
• Version Model Number: CCM10256
• Catalog Number: CCM10256
• Company DUNS: 801089152
• Company Name: ISOTIS ORTHOBIOLOGICS, 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: 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)550-7155
• Email: Irvine.customerservice@seaspin
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspin
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.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
• 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

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981055950 [Primary]
HIBCC	M386CCM102561 [Secondary]

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: 2015-09-24

On-Brand Devices [IsoTis Mozaik Strip]

• M386CCM102561: IsoTis Mozaik™ Strip, 15cc - a resorbable bone void filler made from a bovine collagen matrix
• M386CCM102101: IsoTis Mozaik™ Strip, 10cc - a resorbable bone void filler made from a bovine collagen matrix
• M386CCM101551: IsoTis Mozaik™ Strip, 5cc - a resorbable bone void filler made from a bovine collagen matrix t