Fixture Removal Guide Pins Kit Platform G

GUDID 07340152102225

Surgical Instrument Guide pin used during OPRA™ Fixture removal. Provides a guiding system to centre the Trephine aligned to the Fixture when used together with Guide Sleeve.

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	07340152102225
NIH Device Record Key	a2def411-2708-4521-8817-034e9fcd1251
Commercial Distribution Status	In Commercial Distribution
Brand Name	Fixture Removal Guide Pins Kit Platform G
Version Model Number	2617
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	true
Serial Number	false
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	07340152102225 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P190009

FDA Product Code

PJY	Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees