CURE 2.0™ ACP

GUDID B167T21000001090

MEDITECH SPINE, LLC

Spinal implant trial

• Primary Device ID: B167T21000001090
• NIH Device Record Key: 50544787-6bad-46a2-9c91-7a66a212c9c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CURE 2.0™ ACP
• Version Model Number: T2-10-00001-09
• 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	B167T21000001090 [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

[B167T21000001090]

Moist Heat or Steam Sterilization

[B167T21000001090]

Moist Heat or Steam Sterilization

[B167T21000001090]

Moist Heat or Steam Sterilization

[B167T21000001090]

Moist Heat or Steam Sterilization

[B167T21000001090]

Moist Heat or Steam Sterilization

[B167T21000001090]

Moist Heat or Steam Sterilization

[B167T21000001090]

Moist Heat or Steam Sterilization

[B167T21000001090]

Moist Heat or Steam Sterilization

[B167T21000001090]

Moist Heat or Steam Sterilization

[B167T21000001090]

Moist Heat or Steam Sterilization

[B167T21000001090]

Moist Heat or Steam Sterilization

[B167T21000001090]

Moist Heat or Steam Sterilization

[B167T21000001090]

Moist Heat or Steam Sterilization

[B167T21000001090]

Moist Heat or Steam Sterilization

[B167T21000001090]

Moist Heat or Steam Sterilization

[B167T21000001090]

Moist Heat or Steam Sterilization

[B167T21000001090]

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