aprevo

GUDID 00810056990855

aprevo TLIF-O L5/S1, plan

Carlsmed, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: 00810056990855
• NIH Device Record Key: f88bfcbc-c95b-49c0-a1a9-6433ef2a3777
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: aprevo
• Version Model Number: H.L51.02
• 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	00810056990855 [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