Integra® Proximal Humeral Fracture Plate System HFPLATEIMP

GUDID M268HFPLATEIMP1

The Integra Proximal Humeral Fracture Plate System will be composed of left and right humeral reconstruction plate implants in two options, GT Plate and LP Plate. The plates and screws are made of 316L Stainless Steel. The GT plate is designed to cover the greater tuberosity and is available in four-hole, seven-hole, and ten-hole lengths or sizes. The LP plate is designed to sit lower on the greater tuberosity and is available in three-hole, six-hole, and nine-hole lengths or sizes. The system will also feature 3.5mm locking screws, non-locking compression screws and non-locking partial thread screws. In addition 2.7mm locking screws are also available. The system is indicated for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus. Instruments are provided to assist with the implants.

Ascension Orthopedics, Inc.

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Primary Device ID	M268HFPLATEIMP1
NIH Device Record Key	c16642e5-47a9-40f7-9d39-7c9edff05e1c
Commercial Distribution Discontinuation	2023-03-31
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Integra® Proximal Humeral Fracture Plate System
Version Model Number	HFPLATEIMP
Catalog Number	HFPLATEIMP
Company DUNS	942377524
Company Name	Ascension Orthopedics, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780064626 [Primary]
HIBCC	M268HFPLATEIMP1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K121826

FDA Product Code

HRS	PLATE, FIXATION, BONE