SureMAX

GUDID 00817662020648

SureMAX Cervical Spacer, 0° Parallel Large (15mm x 18mm) x 5mm

ADDITIVE IMPLANTS, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: 00817662020648
• NIH Device Record Key: af3f1ac2-36f2-43a8-a124-f1c55d4c6407
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureMAX
• Version Model Number: 1
• 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

Device Dimensions

• Angle: 0 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817662020648 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182477

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-02-19

On-Brand Devices [SureMAX]

• 00817662024738: Cervical Slap Hammer Handle - Egg
• 00817662024721: Cervical Slap Hammer Handle - Ergonomic
• 00817662024707: Top Barrier, Slap Hammer
• 00817662024691: Central Rod Nut, Slap Hammer
• 00817662024684: Central Rod, Slap Hammer
• 00817662024677: Cervical Slap Hammer Shaft
• 00817662024660: Cervical Slap Hammer
• 00817662024653: Cervical Inserter Rod
• 00817662024646: Cervical Inserter with Guard Assembly
• 00817662024639: Cervical Inserter Shaft with Guard
• 00817662024622: Cervical Inserter without Guard Assembly
• 00817662024615: Proximal Bushing
• 00817662024608: Cervical Inserter Shaft without Guard
• 00817662024592: Cervical Inserter with Guard
• 00817662024585: Cervical Inserter without Guard
• 00817662020716: SureMAX Cervical Spacer, 0° Parallel Large (15mm x 18mm) x 12mm
• 00817662020709: SureMAX Cervical Spacer, 0° Parallel Large (15mm x 18mm) x 11mm
• 00817662020693: SureMAX Cervical Spacer, 0° Parallel Large (15mm x 18mm) x 10mm
• 00817662020686: SureMAX Cervical Spacer, 0° Parallel Large (15mm x 18mm) x 9mm
• 00817662020679: SureMAX Cervical Spacer, 0° Parallel Large (15mm x 18mm) x 8mm
• 00817662020662: SureMAX Cervical Spacer, 0° Parallel Large (15mm x 18mm) x 7mm
• 00817662020655: SureMAX Cervical Spacer, 0° Parallel Large (15mm x 18mm) x 6mm
• 00817662020648: SureMAX Cervical Spacer, 0° Parallel Large (15mm x 18mm) x 5mm
• 00817662020631: SureMAX Cervical Spacer, 0° Parallel Medium (14mm x 16mm) x 12mm
• 00817662020624: SureMAX Cervical Spacer, 0° Parallel Medium (14mm x 16mm) x 11mm
• 00817662020617: SureMAX Cervical Spacer, 0° Parallel Medium (14mm x 16mm) x 10mm
• 00817662020600: SureMAX Cervical Spacer, 0° Parallel Medium (14mm x 16mm) x 9mm
• 00817662020594: SureMAX Cervical Spacer, 0° Parallel Medium (14mm x 16mm) x 8mm
• 00817662020587: SureMAX Cervical Spacer, 0° Parallel Medium (14mm x 16mm) x 7mm
• 00817662020570: SureMAX Cervical Spacer, 0° Parallel Medium (14mm x 16mm) x 6mm
• 00817662020563: SureMAX Cervical Spacer, 0° Parallel Medium (14mm x 16mm) x 5mm
• 00817662020556: SureMAX Cervical Spacer, 0° Parallel Small (12mm x 14mm) x 12mm
• 00817662020549: SureMAX Cervical Spacer, 0° Parallel Small (12mm x 14mm) x 11mm
• 00817662020532: SureMAX Cervical Spacer, 0° Parallel Small (12mm x 14mm) x 10mm
• 00817662020525: SureMAX Cervical Spacer, 0° Parallel Small (12mm x 14mm) x 9mm
• 00817662020518: SureMAX Cervical Spacer, 0° Parallel Small (12mm x 14mm) x 8mm
• 00817662020501: SureMAX Cervical Spacer, 0° Parallel Small (12mm x 14mm) x 7mm
• 00817662020495: SureMAX Cervical Spacer, 0° Parallel Small (12mm x 14mm) x 6mm
• 00817662020488: SureMAX Cervical Spacer, 0° Parallel Small (12mm x 14mm) x 5mm
• 00817662020471: SureMAX Cervical Spacer, 14° Hyperlordotic Large (15mm x 18mm) x 12mm
• 00817662020464: SureMAX Cervical Spacer, 14° Hyperlordotic Large (15mm x 18mm) x 11mm
• 00817662020457: SureMAX Cervical Spacer, 14° Hyperlordotic Large (15mm x 18mm) x 10mm
• 00817662020440: SureMAX Cervical Spacer, 14° Hyperlordotic Large (15mm x 18mm) x 9mm
• 00817662020433: SureMAX Cervical Spacer, 14° Hyperlordotic Large (15mm x 18mm) x 8mm
• 00817662020426: SureMAX Cervical Spacer, 14° Hyperlordotic Large (15mm x 18mm) x 7mm
• 00817662020419: SureMAX Cervical Spacer, 14° Hyperlordotic Large (15mm x 18mm) x 6mm
• 00817662020402: SureMAX Cervical Spacer, 14° Hyperlordotic Large (15mm x 18mm) x 5mm
• 00817662020396: SureMAX Cervical Spacer, 14° Hyperlordotic Medium (14mm x 16mm) x 12mm
• 00817662020389: SureMAX Cervical Spacer, 14° Hyperlordotic Medium (14mm x 16mm) x 11mm
• 00817662020372: SureMAX Cervical Spacer, 14° Hyperlordotic Medium (14mm x 16mm) x 10mm