CURE 2.0™ ACP

GUDID B167T21000001050

MEDITECH SPINE, LLC

Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial

• Primary Device ID: B167T21000001050
• NIH Device Record Key: adc6744d-4f21-4480-8892-97df908179c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CURE 2.0™ ACP
• Version Model Number: T2-10-00001-05
• Company DUNS: 182698477
• Company Name: MEDITECH SPINE, 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B167T21000001050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210286

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[B167T21000001050]

Moist Heat or Steam Sterilization

[B167T21000001050]

Moist Heat or Steam Sterilization

[B167T21000001050]

Moist Heat or Steam Sterilization

[B167T21000001050]

Moist Heat or Steam Sterilization

[B167T21000001050]

Moist Heat or Steam Sterilization

[B167T21000001050]

Moist Heat or Steam Sterilization

[B167T21000001050]

Moist Heat or Steam Sterilization

[B167T21000001050]

Moist Heat or Steam Sterilization

[B167T21000001050]

Moist Heat or Steam Sterilization

[B167T21000001050]

Moist Heat or Steam Sterilization

[B167T21000001050]

Moist Heat or Steam Sterilization

[B167T21000001050]

Moist Heat or Steam Sterilization

[B167T21000001050]

Moist Heat or Steam Sterilization

[B167T21000001050]

Moist Heat or Steam Sterilization

[B167T21000001050]

Moist Heat or Steam Sterilization

[B167T21000001050]

Moist Heat or Steam Sterilization

[B167T21000001050]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-18
• Device Publish Date: 2022-02-10

On-Brand Devices [CURE 2.0™ ACP]

• B167T21000001100: T2-10-00001-10
• B167T21000001090: T2-10-00001-09
• B167T21000001080: T2-10-00001-08
• B167T21000001070: T2-10-00001-07
• B167T21000001060: T2-10-00001-06
• B167T21000001050: T2-10-00001-05
• B167T1000003620: T-10-00003-62
• B167T1000003590: T-10-00003-59
• B167T1000003560: T-10-00003-56
• B167T1000003530: T-10-00003-53
• B167T1000003500: T-10-00003-50
• B167T1000003470: T-10-00003-47
• B167T1000002460: T-10-00002-46
• B167T1000002440: T-10-00002-44
• B167T1000002420: T-10-00002-42
• B167T1000002400: T-10-00002-40
• B167T1000002380: T-10-00002-38
• B167T1000002360: T-10-00002-36
• B167T1000002340: T-10-00002-34
• B167T1000002320: T-10-00002-32
• B167T1000001260: T-10-00001-26
• B167T1000001240: T-10-00001-24
• B167T1000001220: T-10-00001-22
• B167T1000001200: T-10-00001-20
• B167T1000001180: T-10-00001-18
• B167T1000001160: T-10-00001-16
• B167S11000003620: S1-10-00003-62
• B167S11000003590: S1-10-00003-59
• B167S11000003560: S1-10-00003-56
• B167S11000003530: S1-10-00003-53
• B167S11000003500: S1-10-00003-50
• B167S11000003470: S1-10-00003-47
• B167S11000002460: S1-10-00002-46
• B167S11000002440: S1-10-00002-44
• B167S11000002420: S1-10-00002-42
• B167S11000002400: S1-10-00002-40
• B167S11000002380: S1-10-00002-38
• B167S11000002360: S1-10-00002-36
• B167S11000002340: S1-10-00002-34
• B167S11000002320: S1-10-00002-32
• B167S11000001260: S1-10-00001-26
• B167S11000001240: S1-10-00001-24
• B167S11000001220: S1-10-00001-22
• B167S11000001200: S1-10-00001-20
• B167S11000001180: S1-10-00001-18
• B167S11000001160: S1-10-00001-16
• B167100046200: 1000-462-00
• B1671000422000: 1000-422-00
• B1671000420000: 1000-420-00
• B1671000412000: 1000-412-00