Integra® Proximal Humeral Fracture Plate System

Basic Information

• Brand Name: Integra® Proximal Humeral Fracture Plate System
• Primary DI: 10381780120865
• Version / Model: HFP0930106RS
• Catalog Number: HFP0930106RS
• Company Name: Ascension Orthopedics, Inc.
• Labeler DUNS: 942377524
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-09
• Public Version: 5
• Public Version Date: 2023-02-22
• Public Version Status: Update
• Public Device Record Key: c6f8577f-c007-441f-af0b-16f4fef20973
• Distribution End Date: 2026-12-31

Device Description

The Integra Proximal Humeral Fracture Plate System is composed of this right reconstruction plate implant. The plate is made from stainless steel. The low profile humeral fracture plate is designed to sit lower on the greater tuberosity and is available in six-hole.

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: 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
HRS	PLATE, FIXATION, BONE	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62467	Surgical soft-tissue manipulation forceps, alligator, reusable	A long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]; it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780120865	GS1
Secondary	M268HFP0930106RS1	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K121826	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			4.405 mm L