FDA.reportPublic FDA data

Biomet SpinalPak / OrthoPak

Primary DI
00812301020188
Brand
Biomet SpinalPak / OrthoPak
Company
EBI, LLC
Model
106130-12
Catalog number
106130-12
Device description
ELECTRODES, LT-4500
Published
2014-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous
LOFStimulator, Bone Growth, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2
LOFStimulator, Bone Growth, Non-InvasiveUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P850022006

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P850022006Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System; Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator SyAhp Eos Buyer, Inc.1986-02-18LOF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812301020188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812301020188008123010201888123010201880812301020188

GMDN Terms#

Term, Definition table
TermDefinition
Patient-worn bone growth electromagnetic stimulatorA battery-powered, body-worn device designed to apply an electrical stimulus directly to bone to promote bone formation (i.e., osteogenesis). It is intended to generate an electromagnetic (EM) field (and its associated induced voltage effects) around a fracture or fusion site; it is not intended to apply an electric current directly to the body. The device is used as an alternative to bone grafting for non-union fractures (a condition in which the ends of a fractured bone fail to unite), and as a spinal fusion adjunct in treating degenerative vertebral diseases. It is also known as an osteogenesis stimulator.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.973.299.9300btbs.csorders@biomet.com

Regulatory Flags#

DUNS number
050410323
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304820852Biomet SpinalPak / OrthoPak106130-22106130-222016-06-07
00812301020201Biomet SpinalPak / OrthoPak106130-20106130-202014-09-19
00812301020515Biomet EBI Bone Healing System106822610682262014-09-19
00888480588528Reficio DBM Paste207002212015-10-19
00888480588535Reficio DBM Paste207003212015-10-19
00888480588542Reficio DBM Paste207004212015-10-19
00888480588559Reficio DBM Plus208005212015-10-19
00888480588566Reficio DBM Plus209003212015-10-19
00888480588573Reficio DBM Plus209004212015-10-19
00888480588580Reficio DBM Plus209005212015-10-19
00887868269264Biomet SpinalPak Non-invasive Spine Fusion Stimulator System1067716-451067716-452019-02-28
00887868269271Biomet SpinalPak Non-invasive Spine Fusion Stimulator System1067716-631067716-632019-02-28
00887868269288Biomet SpinalPak Non-invasive Spine Fusion Stimulator System1067716-721067716-722019-02-28
00887868269295Biomet OrthoPak Non-invasive Bone Growth Stimulator System1067718-451067718-452019-02-28
00887868269301Biomet OrthoPak Non-invasive Bone Growth Stimulator System1067718-631067718-632019-02-28
00887868269318Biomet OrthoPak Non-invasive Bone Growth Stimulator System1067718-721067718-722019-02-28
00880304820845Biomet SpinalPak / OrthoPak106130-14106130-142016-06-07
00812301020010EBI OsteoGen Implantable Bone Growth Stimulator10-131810-13182014-09-19
00812301020027EBI OsteoGen™ Implantable Bone Growth Stimulator10-132010-13202014-09-19
00812301020034EBI OsteoGen™ Implantable Bone Growth Stimulator10-1320M10-1320M2014-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.GXY2026-09-04
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08720791379148EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379155EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379162EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379179EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379209EZ1020Technomed Engineering B.V.GXY2026-08-07
00190446898610CMFDJO, LLCLOF2026-07-31
00190446922490CMFDJO, LLCLOF2026-07-31
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
00850080988633AUVONUAN HEALTHCARE LIMITEDGXY2026-07-17
18257200164318STIM onTrackOrthofix US LLCLOF2026-07-17
18257200164325STIM onTrackOrthofix US LLCLOF2026-07-17
00850080988602AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988619AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
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00850053287411ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287428ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287442ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287459ReCureNiche Biomedical, Inc.GXY2026-07-14
00850080988589AUVONUAN HEALTHCARE LIMITEDGXY2026-07-14
06971292004318AUVONShenzhen Yuwen E-Commerce Co., Ltd.GXY2026-07-13
08682250582004Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08682250582011Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08720791378172Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378189Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378196Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378202Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378219Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378226Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08