PMA P910066S027

Device: OL1000, OL1000 SC, SPINALOGIC
Applicant: Djo, LLC
PMA number: P910066
Supplement: S027
Product code: LOF
Decision date: 2015-07-24
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: APPROVAL FOR THE LABELING TO BE IN CONFORMANCE WITH IEC 60601-1-6 ED. 3.1, IEC 60601-1-2: 2007, ANSI/AAMI ES 60601-1: 2005/A1:2012 AND IEC 60601-1-11: 2011.

Current openFDA PMA Record#

Device: OL1000, OL1000 SC, SPINALOGIC
Applicant: Djo, LLC
PMA number: P910066
Supplement: S027
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 2015-07-24
Decision code: APPR
Date received: 2015-06-24
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE LABELING TO BE IN CONFORMANCE WITH IEC 60601-1-6 ED. 3.1, IEC 60601-1-2: 2007, ANSI/AAMI ES 60601-1: 2005/A1:2012 AND IEC 60601-1-11: 2011.