PMA P850007S017

Device: SPINAL-STIM(R) MODEL 8212C
Applicant: Orthofix, Inc.
PMA number: P850007
Supplement: S017
Product code: LOF
Decision date: 1997-01-09
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: APPROVAL FOR THE MODEL 8000C CONTROL UNIT WHICH IS TO BE USED IN CONJUNCTION WITH THE EXISTING MODEL 212 TREATMENT TRANSDUCERS, AND FOR MINOR MODIFICATIONS TO THE LABELING OF THE PHYSICIAN MANUAL REGARDING PATIENT COMPLIANCE DATA RETRIEVAL AND ERASURE. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME SPINAL-STIM(R) AND IS INDICATED AS A SURGICAL ADJUNCT FOR SPINAL FUSION OR AS A NONOPERATIVE TREATMENT WHERE AT LEAST NINE MONTHS HAVE ELAPSED SINCE THE LAST SURGERY.

Current openFDA PMA Record#

Device: SPINAL-STIM(R) MODEL 8212C
Applicant: Orthofix, Inc.
PMA number: P850007
Supplement: S017
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 1997-01-09
Decision code: APPR
Date received: 1995-06-16
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE MODEL 8000C CONTROL UNIT WHICH IS TO BE USED IN CONJUNCTION WITH THE EXISTING MODEL 212 TREATMENT TRANSDUCERS, AND FOR MINOR MODIFICATIONS TO THE LABELING OF THE PHYSICIAN MANUAL REGARDING PATIENT COMPLIANCE DATA RETRIEVAL AND ERASURE. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME SPINAL-STIM(R) AND IS INDICATED AS A SURGICAL ADJUNCT FOR SPINAL FUSION OR AS A NONOPERATIVE TREATMENT WHERE AT LEAST NINE MONTHS HAVE ELAPSED SINCE THE LAST SURGERY.