GPC

Basic Information

• Brand Name: GPC
• Primary DI: 08905892045295
• Version / Model: 700.65T
• Company Name: GPC MEDICAL LIMITED
• Labeler DUNS: 915882579
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-04
• Public Version: 1
• Public Version Date: 2025-09-12
• Public Version Status: New
• Public Device Record Key: 5a184993-834a-4824-b29b-26f554a01b19

Device Description

fixLOCK Self Tapping Screw 5.0 mm - Titanium

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: Yes
• 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
HWC	Screw, Fixation, Bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66946	Femoral neck fixation sliding bone screw	A dedicated, partially-threaded rod intended to be implanted through the sleeve of a femoral neck fixation plate/sleeve (not included) and into the neck and head of the femur to treat a trochanteric fracture. It is commonly referred to as a dynamic hip screw or lag screw, however it has no screw head, but instead includes a female thread at the proximal end to accept a compression screw.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08905892045295	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K153716	000