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.

Surgical soft-tissue manipulation forceps, alligator, reusable

• 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

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[M268HFPLATEIMP1]

Moist Heat or Steam Sterilization

[M268HFPLATEIMP1]

Moist Heat or Steam Sterilization

[M268HFPLATEIMP1]

Moist Heat or Steam Sterilization

[M268HFPLATEIMP1]

Moist Heat or Steam Sterilization

[M268HFPLATEIMP1]

Moist Heat or Steam Sterilization

[M268HFPLATEIMP1]

Moist Heat or Steam Sterilization

[M268HFPLATEIMP1]

Moist Heat or Steam Sterilization

[M268HFPLATEIMP1]

Moist Heat or Steam Sterilization

[M268HFPLATEIMP1]

Moist Heat or Steam Sterilization

[M268HFPLATEIMP1]

Moist Heat or Steam Sterilization

[M268HFPLATEIMP1]

Moist Heat or Steam Sterilization

[M268HFPLATEIMP1]

Moist Heat or Steam Sterilization

[M268HFPLATEIMP1]

Moist Heat or Steam Sterilization

[M268HFPLATEIMP1]

Moist Heat or Steam Sterilization

[M268HFPLATEIMP1]

Moist Heat or Steam Sterilization

[M268HFPLATEIMP1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-05-02
• Device Publish Date: 2015-09-22

On-Brand Devices [Integra® Proximal Humeral Fracture Plate System]

• M269HFP0930109LS1: The Integra Proximal Humeral Fracture Plate System is composed of this left reconstruction plate
• M269HFP0930109RS1: The Integra Proximal Humeral Fracture Plate System is composed of this right reconstruction plat
• 10381780120872: The Integra Proximal Humeral Fracture Plate System is composed of this left reconstruction plate
• 10381780120865: The Integra Proximal Humeral Fracture Plate System is composed of this right reconstruction plat
• 10381780120858: The Integra Proximal Humeral Fracture Plate System is composed of this left reconstruction plate
• 10381780120841: The Integra Proximal Humeral Fracture Plate System is composed of this right reconstruction plat
• 10381780120834: The Integra Proximal Humeral Fracture Plate System is composed of this left reconstruction plate
• 10381780120827: The Integra Proximal Humeral Fracture Plate System is composed of this right reconstruction plat
• 10381780120810: The Integra Proximal Humeral Fracture Plate System is composed of this left reconstruction plate
• 10381780120803: The Integra Proximal Humeral Fracture Plate System is composed of this right reconstruction plat
• 10381780120797: The Integra Proximal Humeral Fracture Plate System is composed of this right reconstruction plat
• 10381780120780: The Integra Proximal Humeral Fracture Plate System is composed of this left reconstruction plate
• M269PSS3575PS1: The non-locking partial threaded screw is made from stainless steel and is used in conjunction w
• M269PSS3570PS1: The non-locking partial threaded screw is made from stainless steel and is used in conjunction w
• M269PSS3565PS1: The non-locking partial threaded screw is made from stainless steel and is used in conjunction w
• M269PSS3560PS1: The non-locking partial threaded screw is made from stainless steel and is used in conjunction w
• M269PSS3555PS1: The non-locking partial threaded screw is made from stainless steel and is used in conjunction w
• 10381780121282: The non-locking partial threaded screw is made from stainless steel and is used in conjunction w
• M269PSS3545PS1: The non-locking partial threaded screw is made from stainless steel and is used in conjunction w
• M269PSS3540PS1: The non-locking partial threaded screw is made from stainless steel and is used in conjunction w
• 10381780121251: The locking screw is made from stainless steel and is used in conjunction with the Integra Proxi
• M269PSS3570LS1: The locking screw is made from stainless steel and is used in conjunction with the Integra Proxi
• M269PSS3565LS1: The locking screw is made from stainless steel and is used in conjunction with the Integra Proxi
• M269PSS3560LS1: The locking screw is made from stainless steel and is used in conjunction with the Integra Proxi
• M269PSS3555LS1: The locking screw is made from stainless steel and is used in conjunction with the Integra Proxi
• M269PSS3550LS1: The locking screw is made from stainless steel and is used in conjunction with the Integra Proxi
• M269PSS3545LS1: The locking screw is made from stainless steel and is used in conjunction with the Integra Proxi
• M269PSS3540LS1: The locking screw is made from stainless steel and is used in conjunction with the Integra Proxi
• M269PSS3537LS1: The locking screw is made from stainless steel and is used in conjunction with the Integra Proxi
• M269PSS3535LS1: The locking screw is made from stainless steel and is used in conjunction with the Integra Proxi
• M269PSS3532LS1: The locking screw is made from stainless steel and is used in conjunction with the Integra Proxi
• M269PSS3530LS1: The locking screw is made from stainless steel and is used in conjunction with the Integra Proxi
• M269PSS3527LS1: The locking screw is made from stainless steel and is used in conjunction with the Integra Proxi
• M269PSS3525LS1: The locking screw is made from stainless steel and is used in conjunction with the Integra Proxi
• M269PSS3522LS1: The locking screw is made from stainless steel and is used in conjunction with the Integra Proxi
• M269PSS3520LS1: The locking screw is made from stainless steel and is used in conjunction with the Integra Proxi
• M269PSS3517LS1: The locking screw is made from stainless steel and is used in conjunction with the Integra Proxi
• M269PSS3515LS1: The locking screw is made from stainless steel and is used in conjunction with the Integra Proxi
• M269PSS3540CS1: The non-locking compression screw is made from stainless steel and is used in conjunction with t
• M269PSS3537CS1: The non-locking compression screw is made from stainless steel and is used in conjunction with t
• 10381780121053: The non-locking compression screw is made from stainless steel and is used in conjunction with t
• M269PSS3532CS1: The non-locking compression screw is made from stainless steel and is used in conjunction with t
• 10381780121039: The non-locking compression screw is made from stainless steel and is used in conjunction with t
• M269PSS3527CS1: The non-locking compression screw is made from stainless steel and is used in conjunction with t
• M269PSS3525CS1: The non-locking compression screw is made from stainless steel and is used in conjunction with t
• M269PSS3522CS1: The non-locking compression screw is made from stainless steel and is used in conjunction with t
• M269PSS3517CS1: The non-locking compression screw is made from stainless steel and is used in conjunction with t
• M269PSS3515CS1: The non-locking compression screw is made from stainless steel and is used in conjunction with t
• M269PSS2725LS1: The locking screw is made from stainless steel and is used in conjunction with the Integra Proxi
• M269PSS2722LS1: The locking screw is made from stainless steel and is used in conjunction with the Integra Proxi