CURE ACP

Basic Information

• Brand Name: CURE ACP
• Primary DI: B167900430400
• Version / Model: 900-430-40
• Company Name: MEDITECH SPINE, LLC
• Labeler DUNS: 182698477
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-11
• Public Version: 4
• Public Version Date: 2018-11-22
• Public Version Status: Update
• Public Device Record Key: c90e8643-de14-4d5d-8497-eee01844a5a9

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KWQ	Appliance, fixation, spinal intervertebral body	Orthopedic	888.3060	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47563	Fluted surgical drill bit, single-use, non-sterile	A non-sterile shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, its shaft is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device intended to be sterilized prior to use.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B167900430400	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K171538	000