SureMAX-SA 1022-14121406

GUDID 00817662025353

SureMAX-SA — 14° Small 6

ADDITIVE IMPLANTS, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: 00817662025353
• NIH Device Record Key: a8619546-6b9e-4410-894e-dc9da158ea53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureMAX-SA
• Version Model Number: 1
• Catalog Number: 1022-14121406
• 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	00817662025353 [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