FDA.reportPublic FDA data

Biomet SpinalPak / OrthoPak

Primary DI
00880304820852
Brand
Biomet SpinalPak / OrthoPak
Company
EBI, LLC
Model
106130-22
Catalog number
106130-22
Device description
ELECTRODES, 63B, SPINALPAK/ORTHOPAK
Published
2016-06-07
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
00880304820852PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304820852008803048208528803048208520880304820852

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
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
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
00812301020034EBI OsteoGen™ Implantable Bone Growth Stimulator10-1320M10-1320M2014-09-19

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Primary DI, Brand, Company table
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10816312029427Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXY2026-10-27
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00382830063876NatusXLTEKGXY2026-10-15
00382830063883NatusXLTEKGXY2026-10-15
00382830063890NatusXLTEKGXY2026-10-15
00382830063906NatusXLTEKGXY2026-10-15
00382830063913NatusXLTEKGXY2026-10-15
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