SureMAX-SA 1022-07121411

GUDID 00817662024813

SureMAX-SA — 7° Small 11

ADDITIVE IMPLANTS, LLC

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 00817662024813
• NIH Device Record Key: 67e014e7-2b4a-4272-8085-919e65c7d0f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureMAX-SA
• Version Model Number: 1
• Catalog Number: 1022-07121411
• Company DUNS: 057002266
• Company Name: ADDITIVE IMPLANTS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 6027958850
• Email: quality@additiveimplant.com
• Phone: 6027958850
• Email: quality@additiveimplant.com
• Phone: 6027958850
• Email: quality@additiveimplant.com
• Phone: 6027958850
• Email: quality@additiveimplant.com
• Phone: 6027958850
• Email: quality@additiveimplant.com
• Phone: 6027958850
• Email: quality@additiveimplant.com
• Phone: 6027958850
• Email: quality@additiveimplant.com
• Phone: 6027958850
• Email: quality@additiveimplant.com
• Phone: 6027958850
• Email: quality@additiveimplant.com
• Phone: 6027958850
• Email: quality@additiveimplant.com
• Phone: 6027958850
• Email: quality@additiveimplant.com
• Phone: 6027958850
• Email: quality@additiveimplant.com
• Phone: 6027958850
• Email: quality@additiveimplant.com
• Phone: 6027958850
• Email: quality@additiveimplant.com
• Phone: 6027958850
• Email: quality@additiveimplant.com
• Phone: 6027958850
• Email: quality@additiveimplant.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817662024813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211111

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-08
• Device Publish Date: 2021-09-30

On-Brand Devices [SureMAX-SA]

• 00817662026220: Short Handled Driver
• 00817662026039: Helical screw tip
• 00817662026022: SureMAX-SA Sterilization Tray — Base
• 00817662026015: SureMAX-SA Sterlization Tray — Lid
• 00817662026008: Lock Cam Opener
• 00817662025995: AO DRILL
• 00817662025988: COUNTER TORQUE
• 00817662025971: BLADE SCREW TAMP WITH HANDLE
• 00817662025964: BLADE SCREW U-JOINT INSERTER
• 00817662025957: BLADE SCREW STRAIGHT INSERTER
• 00817662025940: HANDLED LOCK CAM DRIVER
• 00817662025933: STRAIGHT HANDLED DRIVER
• 00817662025926: STRAIGHT HANDLED DRILL
• 00817662025919: ANGLED HANDLED AWL
• 00817662025902: STRAIGHT HANDLED AWL
• 00817662025896: DRIVER TIP
• 00817662025889: DRILL TIP
• 00817662025872: INNER SHAFT FOR ANGLED SHAFT
• 00817662025865: ANGLED SHAFT
• 00817662025858: AWL GUIDE SIZE 12
• 00817662025841: AWL GUIDE SIZE 11
• 00817662025834: AWL GUIDE SIZE 10
• 00817662025827: AWL GUIDE SIZE 9
• 00817662025810: AWL GUIDE SIZE 8
• 00817662025803: AWL GUIDE SIZE 7
• 00817662025797: AWL GUIDE SIZE 6
• 00817662025780: AWL GUIDE SIZE 5
• 00817662025773: INNER SHAFT FOR INSERTER AND AWL GUIDES
• 00817662025766: Low Profile Inserter 8-12
• 00817662025759: Low Profile Inserter 5-7
• 00817662025742: SureMAX-SA Helical Screw —20
• 00817662025735: SureMAX-SA Helical Screw —18
• 00817662025728: SureMAX-SA Helical Screw —16
• 00817662025711: SureMAX-SA Helical Screw —14
• 00817662025704: SureMAX-SA – Variable Angle Bone Screw – 20
• 00817662025698: SureMAX-SA – Variable Angle Bone Screw –18
• 00817662025681: SureMAX-SA – Variable Angle Bone Screw –16
• 00817662025674: SureMAX-SA – Variable Angle Bone Screw –14
• 00817662025667: SureMAX-SA – Fixed Angle Bone Screw –20
• 00817662025650: SureMAX-SA – Fixed Angle Bone Screw –18
• 00817662025643: SureMAX-SA – Fixed Angle Bone Screw –16
• 00817662025636: SureMAX-SA – Fixed Angle Bone Screw –14
• 00817662025629: SureMAX-SA — 14° Extra–Large 12
• 00817662025612: SureMAX-SA — 14° Extra–Large 11
• 00817662025605: SureMAX-SA — 14° Extra–Large 10
• 00817662025599: SureMAX-SA — 14° Extra–Large 9
• 00817662025582: SureMAX-SA — 14° Extra–Large 8
• 00817662025575: SureMAX-SA — 14° Extra–Large 7
• 00817662025568: SureMAX-SA — 14° Extra–Large 6
• 00817662025551: SureMAX-SA — 14° Large 12