Stimulator, Bone Growth, Non-invasive

Product Code: LOF

Ultrasonic Medical Devices (Miscellaneous)

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations:

• Radiation Type: Acoustic
• Radition Safety: None
• Annual Reports: No

Products Classified as LOF

4710

Stimulator, Bone Growth, Non-invasive

Total Product Life Cycle (TPLC) Devices

4710

Stimulator, Bone Growth, Non-invasive

Pre-market Approvals for LOF

P030034	CervicalStim	Orthofix, Inc.
P850007	PhysioStim and SpinalStim	Orthofix, Inc.
P790002	Biomet EBI Bone Healing System	EBI, LLC
P850022	Biomet OrthoPak Non-invasive Bone Growth Stimulator System; Biomet SpinalPak Non-invasive Spine Fusion Stimulator System	EBI, LLC
P900009	EXOGEN Ultrasound Bone Healing System	BIOVENTUS LLC
P910066	OL1000/OL1000 SC and SpinaLogic Bone Growth Stimulators	DJO, LLC

Pre-market Notifications for LOF

K822155

ETHICON TEMPORARY CARDIAC PACING WIRE

ETHICON, INC.

Global Unique Device Identification Database

• 00812301020676: Stimulator, Bone Growth, Non-Invasive
• 00812301020669: Stimulator, Bone Growth, Non-Invasive
• 00812301020652: Stimulator, Bone Growth, Non-Invasive
• 00812301020645: Stimulator, Bone Growth, Non-Invasive
• 00812301020638: Stimulator, Bone Growth, Non-Invasive
• 00812301020621: Stimulator, Bone Growth, Non-Invasive
• 00812301020614: Stimulator, Bone Growth, Non-Invasive
• 00812301020607: Stimulator, Bone Growth, Non-Invasive
• 00812301020591: Stimulator, Bone Growth, Non-Invasive
• 00812301020584: Stimulator, Bone Growth, Non-Invasive
• 00812301020577: Stimulator, Bone Growth, Non-Invasive
• 00812301020560: Stimulator, Bone Growth, Non-Invasive
• 00812301020553: Stimulator, Bone Growth, Non-Invasive
• 00812301020546: Stimulator, Bone Growth, Non-Invasive
• 00812301020539: Stimulator, Bone Growth, Non-Invasive

Maude Adverse Events

SPINALPAK STIMULATOR	EBI, LLC.	2020-03-30
CMF SPINALOGIC	DJO, LLC	2020-03-27
SOFT-TOUCH ELECTRODES, 72R	EBI, LLC.	2020-03-27
SOFT-TOUCH ELECTRODES, 63B	EBI, LLC.	2020-03-27
ELECTRODES, LT-4500	EBI, LLC.	2020-03-17
SOFT-TOUCH ELECTRODES, 72R	EBI, LLC.	2020-03-17
SOFT-TOUCH ELECTRODES, 63B	EBI, LLC.	2020-03-12
SPINALPAK ASSEMBLY	EBI, LLC.	2020-03-03
SPINALPAK STIMULATOR	EBI, LLC.	2020-03-03
CMF SPINALOGIC	DJO, LLC	2020-03-02
ELECTRODE COVER PATCHES	EBI, LLC.	2020-02-27
SOFT-TOUCH ELECTRODES, 63B	EBI, LLC.	2020-02-27
SPINALPAK ASSEMBLY	EBI, LLC.	2020-02-27
BIOMET EBI BONE HEALING SYSTEM	EBI, LLC.	2020-02-17
ORTHOPAK ASSEMBLY	EBI, LLC.	2020-02-17
ELECTRODE COVER PATCHES	EBI, LLC.	2020-02-11
SOFT-TOUCH ELECTRODES, 63B	EBI, LLC.	2020-02-11
BIOMET EBI BONE HEALING SYSTEM SFLX 1 COIL	EBI, LLC.	2020-02-04
BIOMET EBI BONE HEALING SYSTEM	EBI, LLC.	2020-02-04
SOFT-TOUCH ELECTRODES, 63B	EBI, LLC.	2020-02-04
SPINALPAK STIMULATOR, BIOMET	EBI, LLC.	2020-01-24
SOFT-TOUCH ELECTRODES, 72R	EBI, LLC.	2020-01-24
ELECTRODES, LT-4500	EBI, LLC.	2020-01-24
SOFT-TOUCH ELECTRODES, 63B	EBI, LLC.	2020-01-23
ELECTRODE COVER PATCHES	EBI, LLC.	2020-01-23
BIOMET EBI BONE HEALING SYSTEM SFLX 2-4 COIL	EBI, LLC.	2020-01-21
ORTHOPAK ASSEMBLY	EBI, LLC.	2020-01-20
BIOMET EBI BONE HEALING SYSTEM	EBI, LLC.	2020-01-14
SOFT-TOUCH ELECTRODES, 72R	EBI, LLC.	2020-01-13
SOFT-TOUCH ELECTRODES, 63B	EBI, LLC.	2020-01-13
ELECTRODES, LT-4500	EBI, LLC.	2020-01-13
BIOMET EBI BONE HEALING SYSTEM	EBI, LLC.	2020-01-13
SOFT-TOUCH ELECTRODES, 72R	EBI, LLC.	2020-01-13
BIOMET EBI BONE HEALING SYSTEM	EBI, LLC.	2020-01-02
SPINALPAK ASSEMBLY	EBI, LLC.	2020-01-02
SPINALPAK ASSEMBLY	EBI, LLC.	2019-12-16
SOFT-TOUCH ELECTRODES, 63B	EBI, LLC.	2019-12-16
ORTHOPAK ASSEMBLY	EBI, LLC.	2019-12-12
SOFT-TOUCH ELECTRODES, 72R	EBI, LLC.	2019-12-05
ELECTRODES, LT-4500	EBI, LLC.	2019-12-05
ELECTRODE COVER PATCHES	EBI, LLC.	2019-12-05
SOFT-TOUCH ELECTRODES, 63B	EBI, LLC.	2019-12-05
BIOMET EBI BONE HEALING SYSTEM	EBI, LLC.	2019-12-03
SPINALPAK ASSEMBLY	EBI, LLC.	2019-11-07
ELECTRODE COVER PATCHES	EBI, LLC.	2019-11-01
SOFT-TOUCH ELECTRODES, 63B	EBI, LLC.	2019-11-01
CMF SPINALOGIC	DJO, LLC	2019-10-31
SOFT-TOUCH ELECTRODES, 63B	EBI, LLC.	2019-10-22
SOFT-TOUCH ELECTRODES, 72R	EBI, LLC.	2019-10-22
SPINALPAK STIMULATOR, BIOMET	EBI, LLC.	2019-10-22