ORTHOLOGIC 1000 BONE GROWTH STIMULATOR

FDA premarket approval P910066/S004 · decided 1997-06-25

Approval details

PMA number

P910066

Supplement

S004

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

ORTHOLOGIC 1000 BONE GROWTH STIMULATOR

Generic name

Stimulator, bone growth, non-invasive

Applicant

Djo, LLC

Date received

1996-04-05

Decision date

1997-06-25

Days to decision

446 days

Decision code

APPR

Product code

LOF

Advisory committee

Orthopedic

Expedited review

No

Location

Vista, CA

Statement

APPROVAL FOR THE ORTHOLOGIC 1000 SINGLE CLOSED COIL SOFT PACK BONE GROWTH STIMULATOR IN SIZES XS, S, M, L, AND XL AND FOR THE ORTHOLOGIC 1000 BONE GROWTH STIMULATOR IN THE MEDIUM SIZE. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES OL 1000-CC AND OL 1000 (MEDIUM) AND ARE INDICATED FOR THE NONINVASIVE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VETEBRAE AND ALL FLAT BONES, WHERE THE WIDTH OF THE NONUNION DEFECT IS LESS THAN ONE-HALF THE WIDTH OF

510(k) clearances by this applicant