aprevo

GUDID 00810056990763

aprevo TLIF-O L2/L3, plan

Carlsmed, Inc.

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: 00810056990763
• NIH Device Record Key: 4114382b-cc62-4911-942c-ca328fe6df18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: aprevo
• Version Model Number: H.L23.02
• Company DUNS: 117449452
• Company Name: Carlsmed, Inc.
• Device Count: 1
• DM Exempt: true
• 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	00810056990763 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210542

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

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: 2021-10-15
• Device Publish Date: 2021-10-07

On-Brand Devices [aprevo]

• 00810056990756: aprevo Inserter
• 00810056990749: aprevo Rod Bending Template, Right
• 00810056990732: aprevo Rod Bending Template, Left
• 00810056990725: aprevo LLIF L5/S1, plus
• 00810056990718: aprevo LLIF L5/S1, plan
• 00810056990701: aprevo LLIF L5/S1, minus
• 00810056990671: aprevo LLIF L4/L5, plus
• 00810056990664: aprevo LLIF L4/L5, plan
• 00810056990657: aprevo LLIF L4/L5, minus
• 00810056990626: aprevo LLIF L3/L4, plus
• 00810056990619: aprevo LLIF L3/L4, plan
• 00810056990602: aprevo LLIF L3/L4, minus
• 00810056990572: aprevo LLIF L2/L3, plus
• 00810056990565: aprevo LLIF L2/L3, plan
• 00810056990558: aprevo LLIF L2/L3, minus
• 00810056990527: aprevo LLIF L1/L2, plus
• 00810056990510: aprevo LLIF L1/L2, plan
• 00810056990503: aprevo LLIF L1/L2, minus
• 00810056990473: aprevo A/LLIF L5/S1, plus
• 00810056990466: aprevo A/LLIF L5/S1, plan
• 00810056990459: aprevo A/LLIF L5/S1, minus
• 00810056990428: aprevo A/LLIF L4/L5, plus
• 00810056990411: aprevo A/LLIF L4/L5, plan
• 00810056990404: aprevo A/LLIF L4/L5, minus
• 00810056990374: aprevo A/LLIF L3/L4, plus
• 00810056990367: aprevo A/LLIF L3/L4, plan
• 00810056990350: aprevo A/LLIF L3/L4, minus
• 00810056990329: aprevo A/LLIF L2/L3, plus
• 00810056990312: aprevo A/LLIF L2/L3, plan
• 00810056990305: aprevo A/LLIF L2/L3, minus
• 00810056990275: aprevo A/LLIF L1/L2, plus
• 00810056990268: aprevo A/LLIF L1/L2, plan
• 00810056990251: aprevo A/LLIF L1/L2, minus
• 00810056990220: aprevo ALIF L5/S1, plus
• 00810056990213: aprevo ALIF L5/S1, plan
• 00810056990206: aprevo ALIF L5/S1, minus
• 00810056990176: aprevo ALIF L4/L5, plus
• 00810056990169: aprevo ALIF L4/L5, plan
• 00810056990152: aprevo ALIF L4/L5, minus
• 00810056990121: aprevo ALIF L3/L4, plus
• 00810056990114: aprevo ALIF L3/L4, plan
• 00810056990107: aprevo ALIF L3/L4, minus
• 00810056990077: aprevo ALIF L2/L3, plus
• 00810056990060: aprevo ALIF L2/L3, plan
• 00810056990053: aprevo ALIF L2/L3, minus
• 00810056990022: aprevo ALIF L1/L2, plus
• 00810056990015: aprevo ALIF L1/L2, plan
• 00810056990008: aprevo ALIF L1/L2, minus
• 00810056990862: aprevo TLIF-O L5/S1, plus
• 00810056990855: aprevo TLIF-O L5/S1, plan