ASCOT

Basic Information

• Brand Name: ASCOT
• Primary DI: 04047844025970
• Version / Model: Cervical plate, 3-level
• Catalog Number: H3-056
• Company Name: SIGNUS Medizintechnik GmbH
• Labeler DUNS: 344203948
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 6
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: 3627d69f-9a07-4f6f-bc34-e6399269027e

Device Description

ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to accommodate anatomic requirements. Fixed and variable angle screws are available in numerous length/ diameter combinations. In addition, a center graft screw is offered.

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
46653	Spinal fixation plate, non-bioabsorbable	A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04047844025970	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K132310	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			56mm

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 35 Degrees Celsius