GTR Implant Set

GUDID 00846468064075

Extended 5 Hole GTR w/4 Cables, 23x261mm

Pioneer Surgical Technology, Inc.

Hip internal fixation system

• Primary Device ID: 00846468064075
• NIH Device Record Key: b193a4a8-eec5-4fab-89ce-4a1c5bd78a41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GTR Implant Set
• Version Model Number: 401-085
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468064075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000734

FDA Product Code

• KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-08

On-Brand Devices [GTR Implant Set]

• 00846468064075: Extended 5 Hole GTR w/4 Cables, 23x261mm
• 00846468064068: Extended 4 Hole GTR w/4 Cables, 23x232mm
• 00846468064051: Integral Long Greater Trochanteric Reattachment Device (GTR) w/4 Cables, 23x121mm
• 00846468064044: Integral Short Greater Trochanteric Reattachment Device (GTR) w/2 Cables, 23x53mm