FDA.reportPublic FDA data

Biomet EBI Bone Healing System

Primary DI
00812301020515
Brand
Biomet EBI Bone Healing System
Company
EBI, LLC
Model
1068226
Catalog number
1068226
Device description
SFLX 2 COIL
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
LOFStimulator, Bone Growth, Non-Invasive

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P790002026

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P790002026Biomet(R) EBI BONE Healing SystemAhp Eos Buyer, Inc.1979-11-06LOF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812301020515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812301020515008123010205158123010205150812301020515

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry
Storage Environment Atmospheric Pressure50 KiloPascal100 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.973.299.9300btbs.csorders@biomet.com
800-526-2579ebi.csorders@highridge.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304820852Biomet SpinalPak / OrthoPak106130-22106130-222016-06-07
00812301020188Biomet SpinalPak / OrthoPak106130-12106130-122014-09-19
00812301020201Biomet SpinalPak / OrthoPak106130-20106130-202014-09-19
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
00850047248107XstimXstim, IncLOF2026-04-08
00850047248008XstimXstim, IncLOF2024-08-16
10850047248005XstimXstim, IncLOF2024-08-16
00850047248015XstimXstim, IncLOF2024-08-16
00850047248022XstimXstim, IncLOF2024-08-16
00850047248039XstimXstim, IncLOF2024-08-16
00850047248046XstimXstim, IncLOF2024-08-16
00850047248053XstimXstim, IncLOF2024-08-16
00850047248060XstimXstim, IncLOF2024-08-16
00850047248077XstimXstim, IncLOF2024-08-16
00850047248084XstimXstim, IncLOF2024-08-16
00850047248091XstimXstim, IncLOF2024-08-16
18257200158706AccelStimOrthofix US LLCLOF2023-06-12
18257200158713AccelStimOrthofix US LLCLOF2023-06-12
18257200158720AccelStimOrthofix US LLCLOF2023-06-12
08050040997336AccelstimIGEA SPALOF2022-11-04
08050040997299AccelstimIGEA SPALOF2022-08-30
08050040997305AccelstimIGEA SPALOF2022-08-30
08050040997312AccelstimIGEA SPALOF2022-08-30
08050040997329AccelstimIGEA SPALOF2022-08-30
08050040997213AccelStimIGEA SPALOF2022-07-14
M937710346601EXOGEN Metatarsal StrapBIOVENTUS LLCLOF2021-12-17
00850372007165ActaStim-S THERAGEN, LLCLOF2021-02-08
00850372007172ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007189ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007196ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007202ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007219ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007226ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007233ActaStim-STHERAGEN, LLCLOF2021-02-08