What is FDA product code LOF?

A non-invasive bone growth stimulator is a prescription device that provides stimulation through electrical, magnetic, or ultrasonic fields. The device is intended to be used externally to promote osteogenesis as an adjunct to primary treatments for fracture fixation and spinal fusion or as a treatment for established nonunions or failed fusions. Please reference: www.federalregister.gov/documents/2026/04/16/2026-07366/physical-medicine-devices-reclassification-of-non-invasive-bone-growth-stimulators.

Biomet SpinalPak / OrthoPak · Stimulator, Bone Growth, Non-Invasive → Physical Medicine

Name: Biomet SpinalPak / OrthoPak
Brand: Biomet SpinalPak / OrthoPak

1manufacturer

18catalogue numbers in this listing

4recalls on this code

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LOF
Manufacturer	City	Province	Registered as	Device types
JKH Health Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	22

Record

Regulatory record for Biomet SpinalPak / OrthoPak
Listed by	EBI, LLC, United States
FDA product code	LOF
Device type	Stimulator, Bone Growth, Non-Invasive
Device class	Class 2
Regulation	21 CFR 890.5870
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	P850022
Record published	2014-09-19
Record revised	2025-07-11 (version 8)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Biomet SpinalPak / OrthoPak
Catalogue number	Size	Status
106130-20		In distribution
1067724-3		In distribution
1067724-1		In distribution
1067724-4		In distribution
1067724-5		In distribution
1067724-2		In distribution
1067723		In distribution
1067721		In distribution
1067720		In distribution
106130-17		In distribution
1067759		In distribution
1067728		In distribution
106130-22		In distribution
106130-12		In distribution
1067728-1		In distribution
1067729		In distribution
1067722		In distribution
106130-14		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Pemf – Physio-Stim	Orthofix US LLC	39
Physio-Stim	Orthofix US LLC	26
Biomet EBI Bone Healing System	EBI, LLC	24
Orthofix Osteogenesis Stimulator	Orthofix US LLC	16
Xstim	Xstim Inc.	11
ActaStim-S	Theragen, Inc.	11
CMF	DJO, LLC	8
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System	EBI, LLC	7
Cervical-Stim	Orthofix US LLC	7
Biomet OrthoPak Non-invasive Bone Growth Stimulator System	EBI, LLC	6
Accelstim	Igea SPA	6
Spinal Stim	Orthofix US LLC	6

Showing 12 of 21. All products under Stimulator, Bone Growth, Non-Invasive

Recalls Naming This Product

2 recalls name this product by its own identifiers, the UDI on its label.

Recalls naming the identifiers of Biomet SpinalPak / OrthoPak
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
EBI, LLC	UDI-DI	2024-03-22	Class II	Device Design	Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment	829 units (2 lead wires assembly)
EBI, LLC	UDI-DI	2024-03-22	Class II	Device Design	Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment	594 units (2 lead wires assembly)

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2024-03-22	Class II	Device Design	Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
2024-03-22	Class II	Device Design	Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment	1412 units ( 2 leads per assembly)

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P210016	2025-01-17	ManaFuse	Enovis
P230025	2024-11-12	Xstim Spine Fusion Stimulator	Xstim Inc.
P790002	2022-11-23	Biomet® OrthoPak Non-invasive Bone Growth Stimulator System	Ahp Eos Buyer, Inc.
P190030	2022-06-17	ActaStim-S Spine Fusion Stimulator	Theragen, Inc.
P210035	2022-05-03	AccelStimTM Bone Growth Stimulator	Orthofix US LLC
P850007	2018-08-22	PhysioStim, SpinalStim	Orthofix SRL
P900009	2017-09-11	EXOGEN Ultrasound Bone Healing System	Bioventus LLC
P850022	2015-09-09	BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATORY SYSTEM AND BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR	Ahp Eos Buyer, Inc.
P030034	2009-09-11	CERVICAL-STIM	Orthofix SRL
P910066	1997-01-03	ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR	DJO, LLC

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Biomet SpinalPak / OrthoPak