Fixture Removal Trephine and Guide Sleeve Kit 21 mm

GUDID 07340152101754

The Fixture removal Trephine is a single use instrument used as a cutting tool that drills (cuts) into the bone around and along the Fixture to enable extraction of the Fixture. The Guide Sleeves are single use instruments. They are used together with the set of guide pins to center the Trephine around the Fixture when the trephine cuts along the Fixture of the bone.

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

Primary Device ID	07340152101754
NIH Device Record Key	0f0eea14-0639-4c67-a75b-7137dffd3926
Commercial Distribution Status	In Commercial Distribution
Brand Name	Fixture Removal Trephine and Guide Sleeve Kit 21 mm
Version Model Number	2545
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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
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	07340152101754 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P190009

FDA Product Code

PJY	Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees