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

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
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
00880304820852Biomet SpinalPak / OrthoPak106130-22106130-222016-06-07
00812301020188Biomet SpinalPak / OrthoPak106130-12106130-122014-09-19
00812301020201Biomet SpinalPak / OrthoPak106130-20106130-202014-09-19
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
00190446898610CMFDJO, LLCLOF2026-07-31
00190446922490CMFDJO, LLCLOF2026-07-31
18257200164318STIM onTrackOrthofix US LLCLOF2026-07-17
18257200164325STIM onTrackOrthofix US LLCLOF2026-07-17
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