PMA P910066S004

Device: ORTHOLOGIC 1000 BONE GROWTH STIMULATOR
Applicant: Djo, LLC
PMA number: P910066
Supplement: S004
Product code: LOF
Decision date: 1997-06-25
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
Approval order 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 THE BONE TO BE TREATED.

Current openFDA PMA Record#

Device: ORTHOLOGIC 1000 BONE GROWTH STIMULATOR
Applicant: Djo, LLC
PMA number: P910066
Supplement: S004
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 1997-06-25
Decision code: APPR
Date received: 1996-04-05
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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 THE BONE TO BE TREATED.