FDA.reportPublic FDA data

SpF XL IIb Implantable Spinal Fusion Stimulator

Primary DI
00812301020089
Brand
SpF XL IIb Implantable Spinal Fusion Stimulator
Company
EBI, LLC
Model
10-1335M
Catalog number
10-1335M
Device description
SPF-XL IIB 2/DM
Published
2014-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LOEStimulator, Invasive Bone Growth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOEStimulator, Invasive Bone GrowthUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P850035032

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P850035032SpF® Implantable Spinal Fusion StimulatorAhp Eos Buyer, Inc.1987-04-30LOE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812301020089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812301020089008123010200898123010200890812301020089

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
Serial number
true
Manufacturing date on label
true
Expiration 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
00812301020515Biomet EBI Bone Healing System106822610682262014-09-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812301020010EBI OsteoGen Implantable Bone Growth StimulatorEBI, LLCLOE2014-09-19
00812301020027EBI OsteoGen™ Implantable Bone Growth StimulatorEBI, LLCLOE2014-09-19
00812301020034EBI OsteoGen™ Implantable Bone Growth StimulatorEBI, LLCLOE2014-09-19
00812301020041EBI OsteoGen™ Implantable Bone Growth StimulatorEBI, LLCLOE2014-09-19
00812301020058EBI OsteoGen™ Implantable Bone Growth StimulatorEBI, LLCLOE2014-09-19
00812301020065EBI OsteoGen™ Implantable Bone Growth StimulatorEBI, LLCLOE2014-09-19
00812301020072EBI OsteoGen™ Implantable Bone Growth StimulatorEBI, LLCLOE2014-09-19
00812301020096SpF®-XL IIb Implantable Spinal Fusion StimulatorEBI, LLCLOE2014-09-19
00812301020102EBI OsteoGen™ Implantable Bone Growth StimulatorEBI, LLCLOE2014-09-19
00812301020119EBI OsteoGen™ Implantable Bone Growth StimulatorEBI, LLCLOE2014-09-19
00812301020126SpF®-PLUS-Mini (60 uA/M)EBI, LLCLOE2014-09-19
00812301020133SpF®-PLUS-Mini (60 uA/W)EBI, LLCLOE2014-09-19