coflex Interlaminar Technology, 16mm

Basic Information

• Brand Name: coflex Interlaminar Technology, 16mm
• Primary DI: 04260148898495
• Version / Model: UPI00016
• Company Name: Paradigm Spine GmbH
• Labeler DUNS: 537619731
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-07-28
• Public Version: 5
• Public Version Date: 2021-06-10
• Public Version Status: Update
• Public Device Record Key: 0170eca5-257f-4c54-acde-d870a01078ba

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 Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
NQO	Prosthesis, Spinous Process Spacer/Plate	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
35642	Internal orthopaedic fixation system, plate/screw, non-bioabsorbable	An assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260148898495	GS1

Premarket Submissions

Submission Number	Supplement Number
P110008	000