Large Fragment Active Plating System

Basic Information

• Brand Name: Large Fragment Active Plating System
• Primary DI: 00866204000259
• Version / Model: 00-505-000-30
• Company Name: Incipio Devices
• Labeler DUNS: 042094056
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-02-24
• Public Version: 5
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: ab82528c-042c-4c4f-a10c-171f5f2f7c76
• Distribution End Date: 2017-09-01

Device Description

5mm Locking Screw, 30mm

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
HWC	Screw, Fixation, Bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34003	Hip internal fixation system	An assembly of implantable devices designed to treat fractures of the hip. It typically includes a metal plate that is held in position with fasteners such as screws and nails, or bolts, nuts and washers. The assembly is typically intended to treat stable or unstable intertrochanteric, pertrochanteric, and/or base of neck hip fractures.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00866204000259	GS1

Premarket Submissions

Submission Number	Supplement Number
K142938	000