SureMAX-X 9102-14152008

GUDID 00817662022383

Cervical Trial, 14° Hyperlordotic Extra-Large (15mm x 20mm) x 8mm

ADDITIVE IMPLANTS, LLC

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00817662022383
• NIH Device Record Key: 2ec3456a-c5b8-40af-b977-53d2636b5817
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureMAX-X
• Version Model Number: 1
• Catalog Number: 9102-14152008
• Company DUNS: 057002266
• Company Name: ADDITIVE IMPLANTS, LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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

Device Dimensions

• Height: 8 Millimeter
• Angle: 14 degree
• Depth: 15 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter
• Angle: 14 degree
• Depth: 15 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter
• Angle: 14 degree
• Depth: 15 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter
• Angle: 14 degree
• Depth: 15 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter
• Angle: 14 degree
• Depth: 15 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter
• Angle: 14 degree
• Depth: 15 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter
• Angle: 14 degree
• Depth: 15 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter
• Angle: 14 degree
• Depth: 15 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter
• Angle: 14 degree
• Depth: 15 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter
• Angle: 14 degree
• Depth: 15 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter
• Angle: 14 degree
• Depth: 15 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter
• Angle: 14 degree
• Depth: 15 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter
• Angle: 14 degree
• Depth: 15 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter
• Angle: 14 degree
• Depth: 15 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817662022383 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193359

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00817662022383]

Moist Heat or Steam Sterilization

[00817662022383]

Moist Heat or Steam Sterilization

[00817662022383]

Moist Heat or Steam Sterilization

[00817662022383]

Moist Heat or Steam Sterilization

[00817662022383]

Moist Heat or Steam Sterilization

[00817662022383]

Moist Heat or Steam Sterilization

[00817662022383]

Moist Heat or Steam Sterilization

[00817662022383]

Moist Heat or Steam Sterilization

[00817662022383]

Moist Heat or Steam Sterilization

[00817662022383]

Moist Heat or Steam Sterilization

[00817662022383]

Moist Heat or Steam Sterilization

[00817662022383]

Moist Heat or Steam Sterilization

[00817662022383]

Moist Heat or Steam Sterilization

[00817662022383]

Moist Heat or Steam Sterilization

[00817662022383]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-07
• Device Publish Date: 2020-04-29

On-Brand Devices [SureMAX-X]

• 00817662022079: SureMAX-X Cervical Spacer, 14° Hyperlordotic Extra-Large (15mm x 20mm) x 9mm
• 00817662022062: SureMAX-X Cervical Spacer, 10° Midlordotic Extra-Large (15mm x 20mm) x 9mm
• 00817662022055: SureMAX-X Cervical Spacer, 7° Lordotic Extra-Large (15mm x 20mm) x 9mm
• 00817662022031: SureMAX-X Cervical Spacer, 14° Hyperlordotic Extra-Large (15mm x 20mm) x 8mm
• 00817662022024: SureMAX-X Cervical Spacer, 10° Midlordotic Extra-Large (15mm x 20mm) x 8mm
• 00817662022017: SureMAX-X Cervical Spacer, 7° Lordotic Extra-Large (15mm x 20mm) x 8mm
• 00817662021997: SureMAX-X Cervical Spacer, 14° Hyperlordotic Extra-Large (15mm x 20mm) x 7mm
• 00817662021980: SureMAX-X Cervical Spacer, 10° Midlordotic Extra-Large (15mm x 20mm) x 7mm
• 00817662021973: SureMAX-X Cervical Spacer, 7° Lordotic Extra-Large (15mm x 20mm) x 7mm
• 00817662021959: SureMAX-X Cervical Spacer, 14° Hyperlordotic Extra-Large (15mm x 20mm) x 6mm
• 00817662021942: SureMAX-X Cervical Spacer, 10° Midlordotic Extra-Large (15mm x 20mm) x 6mm
• 00817662021935: SureMAX-X Cervical Spacer, 7° Lordotic Extra-Large (15mm x 20mm) x 6mm
• 00817662021911: SureMAX-X Cervical Spacer, 14° Hyperlordotic Extra-Large (15mm x 20mm) x 5mm
• 00817662021904: SureMAX-X Cervical Spacer, 10° Midlordotic Extra-Large (15mm x 20mm) x 5mm
• 00817662021898: SureMAX-X Cervical Spacer, 7° Lordotic Extra-Large (15mm x 20mm) x 5mm
• 00817662021874: SureMAX-X Cervical Spacer, 10° Midlordotic Large (15mm x 18mm) x 9mm
• 00817662021867: SureMAX-X Cervical Spacer, 10° Midlordotic Large (15mm x 18mm) x 8mm
• 00817662021850: SureMAX-X Cervical Spacer, 10° Midlordotic Large (15mm x 18mm) x 7mm
• 00817662021843: SureMAX-X Cervical Spacer, 10° Midlordotic Large (15mm x 18mm) x 6mm
• 00817662021836: SureMAX-X Cervical Spacer, 10° Midlordotic Large (15mm x 18mm) x 5mm
• 00817662021829: SureMAX-X Cervical Spacer, 10° Midlordotic Medium (14mm x 16mm) x 9mm
• 00817662021812: SureMAX-X Cervical Spacer, 10° Midlordotic Medium (14mm x 16mm) x 8mm
• 00817662021805: SureMAX-X Cervical Spacer, 10° Midlordotic Medium (14mm x 16mm) x 7mm
• 00817662021799: SureMAX-X Cervical Spacer, 10° Midlordotic Medium (14mm x 16mm) x 6mm
• 00817662021782: SureMAX-X Cervical Spacer, 10° Midlordotic Medium (14mm x 16mm) x 5mm
• 00817662021775: SureMAX-X Cervical Spacer, 10° Midlordotic Small (12mm x 14mm) x 9mm
• 00817662021768: SureMAX-X Cervical Spacer, 10° Midlordotic Small (12mm x 14mm) x 8mm
• 00817662021751: SureMAX-X Cervical Spacer, 10° Midlordotic Small (12mm x 14mm) x 7mm
• 00817662021744: SureMAX-X Cervical Spacer, 10° Midlordotic Small (12mm x 14mm) x 6mm
• 00817662021737: SureMAX-X Cervical Spacer, 10° Midlordotic Small (12mm x 14mm) x 5mm
• 00817662021614: SureMAX-X Cervical Spacer, 14° Hyperlordotic Large (15mm x 18mm) x 9mm
• 00817662021607: SureMAX-X Cervical Spacer, 14° Hyperlordotic Large (15mm x 18mm) x 8mm
• 00817662021591: SureMAX-X Cervical Spacer, 14° Hyperlordotic Large (15mm x 18mm) x 7mm
• 00817662021584: SureMAX-X Cervical Spacer, 14° Hyperlordotic Large (15mm x 18mm) x 6mm
• 00817662021577: SureMAX-X Cervical Spacer, 14° Hyperlordotic Large (15mm x 18mm) x 5mm
• 00817662021553: SureMAX-X Cervical Spacer, 14° Hyperlordotic Medium (14mm x 16mm) x 9mm
• 00817662021546: SureMAX-X Cervical Spacer, 14° Hyperlordotic Medium (14mm x 16mm) x 8mm
• 00817662021539: SureMAX-X Cervical Spacer, 14° Hyperlordotic Medium (14mm x 16mm) x 7mm
• 00817662021522: SureMAX-X Cervical Spacer, 14° Hyperlordotic Medium (14mm x 16mm) x 6mm
• 00817662021515: SureMAX-X Cervical Spacer, 14° Hyperlordotic Medium (14mm x 16mm) x 5mm
• 00817662021492: SureMAX-X Cervical Spacer, 14° Hyperlordotic Small (12mm x 14mm) x 9mm
• 00817662021485: SureMAX-X Cervical Spacer, 14° Hyperlordotic Small (12mm x 14mm) x 8mm
• 00817662021478: SureMAX-X Cervical Spacer, 14° Hyperlordotic Small (12mm x 14mm) x 7mm
• 00817662021461: SureMAX-X Cervical Spacer, 14° Hyperlordotic Small (12mm x 14mm) x 6mm
• 00817662021454: SureMAX-X Cervical Spacer, 14° Hyperlordotic Small (12mm x 14mm) x 5mm
• 00817662021416: SureMAX-X Cervical Spacer, 7° Lordotic Large (15mm x 18mm) x 9mm
• 00817662021409: SureMAX-X Cervical Spacer, 7° Lordotic Large (15mm x 18mm) x 8mm
• 00817662021393: SureMAX-X Cervical Spacer, 7° Lordotic Large (15mm x 18mm) x 7mm
• 00817662021386: SureMAX-X Cervical Spacer, 7° Lordotic Large (15mm x 18mm) x 6mm
• 00817662021379: SureMAX-X Cervical Spacer, 7° Lordotic Large (15mm x 18mm) x 5mm