Biomet SpinalPak Non-invasive Spine Fusion Stimulator System 1067783-2

GUDID 00812301020416

BATTERY DOOR, BIOMET SPINALPAK REPLACEMENT

EBI, LLC

Patient-worn bone growth electromagnetic stimulator
Primary Device ID00812301020416
NIH Device Record Keyc7119679-ed38-4e3d-a1a2-b51d9a5de65a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiomet SpinalPak Non-invasive Spine Fusion Stimulator System
Version Model Number1067783-2
Catalog Number1067783-2
Company DUNS050410323
Company NameEBI, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100812301020416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LOFStimulator, Bone Growth, Non-Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-19

On-Brand Devices [Biomet SpinalPak Non-invasive Spine Fusion Stimulator System]

00812301020416BATTERY DOOR, BIOMET SPINALPAK REPLACEMENT
00812301020348SPINALPAK ASSEMBLY - ROW
00812301020225SPINALPAK STIMULATOR, BIOMET
00812301020218SPINALPAK ASSEMBLY
008878682692881067716-72
008878682692711067716-63
008878682692641067716-45
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