IsoTis Mozaik Putty PTY10210

GUDID M386PTY102101

IsoTis Mozaik™ Putty, 10cc - 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

• Primary Device ID: M386PTY102101
• NIH Device Record Key: fd31eb4a-5caa-4e1c-aa6c-98d37f8ed38b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IsoTis Mozaik Putty
• Version Model Number: PTY10210
• Catalog Number: PTY10210
• 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 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981055912 [Primary]
HIBCC	M386PTY102101 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [IsoTis Mozaik Putty]

• M386PTY102561: IsoTis Mozaik™ Putty, 15cc - a resorbable bone void filler made from a bovine collagen matrix
• M386PTY102101: IsoTis Mozaik™ Putty, 10cc - a resorbable bone void filler made from a bovine collagen matrix
• M386PTY101551: IsoTis Mozaik™ Putty, 5cc - a resorbable bone void filler made from a bovine collagen matrix t
• M386PTY101251: IsoTis Mozaik™ Putty, 2.5cc - a resorbable bone void filler made from a bovine collagen matrix