Instrument Kit: Abutment Extraction PF G USA

GUDID 07340152101976

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

Integrum AB

Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar

Primary Device ID	07340152101976
NIH Device Record Key	70cb2713-dd06-4845-8681-c150d597cf5f
Commercial Distribution Status	In Commercial Distribution
Brand Name	Instrument Kit: Abutment Extraction PF G USA
Version Model Number	2531
Company DUNS	356739813
Company Name	Integrum AB
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	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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340152101976 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P190009

FDA Product Code

PJY	Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees