OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS

FDA premarket approval P910066/S019 · decided 2004-09-10

Approval details

PMA number

P910066

Supplement

S019

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS

Generic name

Stimulator, bone growth, non-invasive

Applicant

Djo, LLC

Date received

2004-01-20

Decision date

2004-09-10

Days to decision

234 days

Decision code

APPR

Product code

LOF

Advisory committee

Orthopedic

Expedited review

No

Location

Vista, CA

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 BENEF

510(k) clearances by this applicant