GTR Implant Set

Basic Information

• Brand Name: GTR Implant Set
• Primary DI: 00846468064075
• Version / Model: 401-085
• Company Name: Pioneer Surgical Technology, Inc.
• Labeler DUNS: 793384496
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-08
• Public Version: 5
• Public Version Date: 2023-11-20
• Public Version Status: Update
• Public Device Record Key: b193a4a8-eec5-4fab-89ce-4a1c5bd78a41

Device Description

Extended 5 Hole GTR w/4 Cables, 23x261mm

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46647	Orthopaedic fixation plate, non-bioabsorbable	A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00846468064075	GS1

Premarket Submissions

Submission Number	Supplement Number
K000734	000