Stimulator, Invasive Bone Growth

Device Code: 4709

Product Code(s): LOE

Device Classification Information

• Device Type ID: 4709
• Device Name: Stimulator, Invasive Bone Growth
• Review Panel: Orthopedic
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Orthopedic Devices (DOD); Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1)
• Submission Type: PMA
• FDA Device Classification: Class 3 Medical Device
• Product Code: LOE
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 4709
• Device: Stimulator, Invasive Bone Growth
• Product Code: LOE
• FDA Device Classification: Class 3 Medical Device

Device Problems
Insufficient Information	6
Failure To Power Up	2
Patient-Device Incompatibility	2
Appropriate Term/Code Not Available	2
Adverse Event Without Identified Device Or Use Problem	1
Migration Or Expulsion Of Device	1
Detachment Of Device Or Device Component	1
Total Device Problems	15

Recalls
Manufacturer		Recall Class	Date Posted
1	EBI Patient Care, Inc.	I	May-26-2017
2	Zimmer Biomet, Inc.	I	Nov-02-2018

TPLC Last Update: 2019-04-02 20:54:16