Instrument Kit: Abutment Extraction PF G USA

Basic Information

• Brand Name: Instrument Kit: Abutment Extraction PF G USA
• Primary DI: 07340152101976
• Version / Model: 2531
• Company Name: Integrum AB
• Labeler DUNS: 356739813
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-25
• Public Version: 1
• Public Version Date: 2023-07-03
• Public Version Status: New
• Public Device Record Key: 70cb2713-dd06-4845-8681-c150d597cf5f

Device Description

The intended purpose is for certified surgeons, to conduct the surgical procedure for Abutment Extraction, facilitate removal of Abutment and Abutment Screw within an OPRA™ Implant System in a patient. Consist of instruments: Clamp head Clamp head Pusher Clamp head Screw Pressure Peg Hex T-Handle 5 mm Spanner 14 mm Spanner 12 mm Spanner 10 mm

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
PJY	Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
58743	Internal-external leg prosthesis osseointegration bar	A rod with a screw-like or press-fit design intended to be implanted into the residual bone of a lower limb (e.g., femur, tibia) after amputation to function as an anchoring fixture and stabilizing bar for the connection of an internal-external leg prosthesis. It is designed to project beyond the bone but not through the skin so that a protruding trans-stomal connector/abutment can be attached to its distal end to interface with the external prosthesis. It is typically composed of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and has a porous surface intended to improve fixation by promoting bone ingrowth (osseointegration).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07340152101976	GS1

Premarket Submissions

Submission Number	Supplement Number
P190009	003