PMA P910066S019

Device: OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS
Applicant: Djo, LLC
PMA number: P910066
Supplement: S019
Product code: LOF
Decision date: 2004-09-10
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: APPROVAL FOR 1) CHANGE IN THE LABELING TO REFLECT THE NEW COMPANY OWNERSHIP FROM ORTHOLOGIC TO DJ ORTHOPEDICS/ REGENTEK; 2) ADDITION OF A PRODUCT SPECIFICATIONS SECTION TO ALL MANUALS TO COMPLY WITH CANADIAN STANDARDS ASSOCIATION. (APPLIES TO OL SERIES AND SPINALOGIC MANUALS); 3) ADDITION OF REFERENCE SECTION (APPLIES TO SPINALOGIC MANUALS ONLY); AND 4) IN RISK AND BENEFITS SECTION OF THE SPINALOGIC PATIENT MANUAL, REVISION THE STATEMENT "20% GREATER CHANCE OF BACK SURGERY HEALING" TO "THE BENEFIT OF THE SPINALOGIC IS THAT YOU HAVE A GREATER CHANCE OF YOUR BACK SURGERY HEALING IF YOU USE THE DEVICE EVERY DAY THAN IF YOU DON NOT USE IT."

Current openFDA PMA Record#

Device: OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS
Applicant: Djo, LLC
PMA number: P910066
Supplement: S019
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 2004-09-10
Decision code: APPR
Date received: 2004-01-20
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR 1) CHANGE IN THE LABELING TO REFLECT THE NEW COMPANY OWNERSHIP FROM ORTHOLOGIC TO DJ ORTHOPEDICS/ REGENTEK; 2) ADDITION OF A PRODUCT SPECIFICATIONS SECTION TO ALL MANUALS TO COMPLY WITH CANADIAN STANDARDS ASSOCIATION. (APPLIES TO OL SERIES AND SPINALOGIC MANUALS); 3) ADDITION OF REFERENCE SECTION (APPLIES TO SPINALOGIC MANUALS ONLY); AND 4) IN RISK AND BENEFITS SECTION OF THE SPINALOGIC PATIENT MANUAL, REVISION THE STATEMENT "20% GREATER CHANCE OF BACK SURGERY HEALING" TO "THE BENEFIT OF THE SPINALOGIC IS THAT YOU HAVE A GREATER CHANCE OF YOUR BACK SURGERY HEALING IF YOU USE THE DEVICE EVERY DAY THAN IF YOU DON NOT USE IT."