Continuum

Basic Information

• Brand Name: Continuum
• Primary DI: 00850039803000
• Version / Model: PS-01-1412A
• Company Name: Pressio, Inc
• Labeler DUNS: 084706556
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-01
• Public Version: 1
• Public Version Date: 2023-05-09
• Public Version Status: New
• Public Device Record Key: ffcbfcf5-545b-4889-8d7f-7fa61a266388

Device Description

ACDF IMPLANT KIT - 14X12MM ANGLED

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PHQ	Anterior Staple As Supplemental Fixation For Fusion	Orthopedic	888.3060	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58235	Memory-alloy orthopaedic fixation plate	A non-sterile implantable device made of a shape memory alloy (SMA) [e.g., nickel-titanium alloy (Nitinol)] designed for the fixation of a bone fracture without the use of screws or wires or other holding devices. It typically consists of a cylindrical or conical plate with a pair or pairs of gripping arms to bridge and stabilize the fracture gap of a bone, e.g., long bones, rib and sternum, and shield the site from stress as the bone heals. Compression is achieved by the temperature-controlled properties of the SMA. It is available in a variety of sizes and is typically surgically removed after the healing process. It is a single-use device intended to be sterilized prior to use.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850039803000	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K200301	000