Accell Evo3 Putty 02-5000-010

GUDID 10889981129712

Accell Evo3 Putty, 1cc - demineralized human bone mixed with poloxamer resorbable reverse phase medium. Accell Evo3 is formulated into a putty form a

SEASPINE ORTHOPEDICS CORPORATION

Bone matrix implant, human-derived

• Primary Device ID: 10889981129712
• NIH Device Record Key: 5d92d533-62c8-4936-bc83-dc63c3f6076c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accell Evo3 Putty
• Version Model Number: 02-5000-010
• Catalog Number: 02-5000-010
• Company DUNS: 079840876
• Company Name: SEASPINE ORTHOPEDICS 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: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981129712 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061880

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: 2016-10-21

Devices Manufactured by SEASPINE ORTHOPEDICS CORPORATION

• 00889981124017 - Shoreline ACS: 2024-12-30 No Profile Spacer, 16x14x6mm, 7 Degree, Sterile
• 00889981124024 - Shoreline ACS: 2024-12-30 No Profile Spacer, 16x14x7mm, 7 Degree, Sterile
• 00889981124031 - Shoreline ACS: 2024-12-30 No Profile Spacer, 16x14x8mm, 7 Degree, Sterile
• 00889981124048 - Shoreline ACS: 2024-12-30 No Profile Spacer, 16x14x9mm, 7 Degree, Sterile
• 00889981124055 - Shoreline ACS: 2024-12-30 No Profile Spacer, 16x14x10mm, 7 Degree, Sterile
• 00889981124062 - Shoreline ACS: 2024-12-30 No Profile Spacer, 16x14x11mm, 7 Degree, Sterile
• 00889981124079 - Shoreline ACS: 2024-12-30 No Profile Spacer, 16x14x12mm, 7 Degree, Sterile
• 00889981124086 - Shoreline ACS: 2024-12-30 No Profile Spacer, 18x15x6mm, 7 Degree, Sterile