aprevo®

GUDID 00810056992965

aprevo® ACDF-X Locking Screw, Ø3.5x20mm / 3 PK

Carlsmed, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: 00810056992965
• NIH Device Record Key: 8b58e96e-3c37-4564-a29a-1fb77019d925
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: aprevo®
• Version Model Number: 1098.20.3
• Company DUNS: 117449452
• Company Name: Carlsmed, Inc.
• 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: true
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810056992965 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242260

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: 2025-07-01
• Device Publish Date: 2025-06-23

On-Brand Devices [aprevo®]

• 00810056993030: aprevo® Angled Driver
• 00810056993023: aprevo® Angled Awl
• 00810056993016: aprevo® Straight Driver
• 00810056993009: aprevo® Straight Awl
• 00810056992996: aprevo® ALIF-X Locking Screw, Ø5.5x40mm / 3PK
• 00810056992989: aprevo® ALIF-X Locking Screw, Ø5.5x35mm / 3PK
• 00810056992972: aprevo® Cervical AO Handle
• 00810056992965: aprevo® ACDF-X Locking Screw, Ø3.5x20mm / 3 PK
• 00810056992873: aprevo® ACDF-X Locking Screw, Ø3.5x17mm / 3 PK
• 00810056992811: aprevo® ACDF-X Locking Screw, Ø3.5x15mm / 3 PK
• 00810056992750: aprevo® ACDF-X Locking Screw, Ø3.5x13mm / 3 PK
• 00810056992620: aprevo® ACDF C8/T1, plus
• 00810056992613: aprevo® ACDF C8/T1, plan
• 00810056992583: aprevo® ACDF C7/T1, plus
• 00810056992576: aprevo® ACDF C7/T1, plan
• 00810056992545: aprevo® ACDF C7/C8, plus
• 00810056992538: aprevo® ACDF C7/C8, plan
• 00810056992507: aprevo® ACDF C6/C7, plus
• 00810056992491: aprevo® ACDF C6/C7, plan
• 00810056992460: aprevo® ACDF C5/C6, plus
• 00810056992453: aprevo® ACDF C5/C6, plan
• 00810056992422: aprevo® ACDF C4/C5, plus
• 00810056992415: aprevo® ACDF C4/C5, plan
• 00810056992385: aprevo® ACDF C3/C4, plus
• 00810056992378: aprevo® ACDF C3/C4, plan
• 00810056992347: aprevo® ACDF C2/C3, plus
• 00810056992330: aprevo® ACDF C2/C3, plan
• 00810056992019: aprevo® Cervical Distractor, 6x15
• 00810056992002: aprevo® Cervical Distractor, 5x15
• 00810056991999: aprevo® Cervical Angled Awl
• 00810056991982: aprevo® Cervical Distractor, 4x15
• 00810056991975: aprevo® Cervical Straight Awl
• 00810056991968: aprevo® Cervical Distractor, 3x15
• 00810056991951: aprevo® Cervical Angled Driver
• 00810056991944: aprevo® Cervical Distractor, 6x14
• 00810056991920: aprevo® Cervical Distractor, 5x14
• 00810056991906: aprevo® Cervical Distractor, 4x14
• 00810056991883: aprevo® Cervical Distractor, 3x14
• 00810056991876: aprevo® Cervical Straight Driver
• 00810056991869: aprevo® Cervical Inserter