CURE™ ACP

GUDID B167700460000

MEDITECH SPINE, LLC

General internal orthopaedic fixation system implantation kit

• Primary Device ID: B167700460000
• NIH Device Record Key: 3721a021-5b41-446b-bfc2-2fb64a726a42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CURE™ ACP
• Version Model Number: 700-460-00
• 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: true
• 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	B167700460000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160604

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[B167700460000]

Moist Heat or Steam Sterilization

[B167700460000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-10

On-Brand Devices [CURE™ ACP]

• B167T740044990: T-7-40044-99
• B167T740044980: T-7-40044-98
• B167T740044970: T-7-40044-97
• B167T740044960: T-7-40044-96
• B167T740044950: T-7-40044-95
• B167T740044940: T-7-40044-94
• B167T740044930: T-7-40044-93
• B167T740044920: T-7-40044-92
• B167T740044910: T-7-40044-91
• B167T740044900: T-7-40044-90
• B167T740044890: T-7-40044-89
• B167T740044880: T-7-40044-88
• B167T740044870: T-7-40044-87
• B167T740044860: T-7-40044-86
• B167T740044850: T-7-40044-85
• B167T740044840: T-7-40044-84
• B167T740044830: T-7-40044-83
• B167T740044820: T-7-40044-82
• B167T740044810: T-7-40044-81
• B167T740044800: T-7-40044-80
• B167T740044790: T-7-40044-79
• B167T740044780: T-7-40044-78
• B167T740044770: T-7-40044-77
• B167T740044760: T-7-40044-76
• B167T740044750: T-7-40044-75
• B167T740044740: T-7-40044-74
• B167T740044730: T-7-40044-73
• B167T740044720: T-7-40044-72
• B167T740044710: T-7-40044-71
• B167T740044700: T-7-40044-70
• B167T740044690: T-7-40044-69
• B167T740044680: T-7-40044-68
• B167T740044670: T-7-40044-67
• B167T740044660: T-7-40044-66
• B167T740044650: T-7-40044-65
• B167T740044640: T-7-40044-64
• B167T740044630: T-7-40044-63
• B167T740044620: T-7-40044-62
• B167T740044610: T-7-40044-61
• B167T740044600: T-7-40044-60
• B167T740044590: T-7-40044-59
• B167T740044580: T-7-40044-58
• B167T740044570: T-7-40044-57
• B167T740044560: T-7-40044-56
• B167T7400441060: T-7-40044-106
• B167T7400441050: T-7-40044-105
• B167T7400441040: T-7-40044-104
• B167T7400441030: T-7-40044-103
• B167T7400441020: T-7-40044-102
• B167T7400441010: T-7-40044-101