SpF®-PLUS-Mini (60 uA/W) 10-1398W

GUDID 00812301020133

SPF-PLUS 60/W Implantable Spinal Fusion Stimulator

EBI, LLC

Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator
Primary Device ID00812301020133
NIH Device Record Key5809fb58-20de-4476-b6cf-16ad16f58da5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpF®-PLUS-Mini (60 uA/W)
Version Model Number10-1398W
Catalog Number10-1398W
Company DUNS050410323
Company NameEBI, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100812301020133 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LOEStimulator, Invasive Bone Growth

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

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

Devices Manufactured by EBI, LLC

00887868269264 - Biomet SpinalPak Non-invasive Spine Fusion Stimulator System2019-03-11
00887868269271 - Biomet SpinalPak Non-invasive Spine Fusion Stimulator System2019-03-11
00887868269288 - Biomet SpinalPak Non-invasive Spine Fusion Stimulator System2019-03-11
00887868269295 - Biomet OrthoPak Non-invasive Bone Growth Stimulator System2019-03-11
00887868269301 - Biomet OrthoPak Non-invasive Bone Growth Stimulator System2019-03-11
00887868269318 - Biomet OrthoPak Non-invasive Bone Growth Stimulator System2019-03-11
00880304820845 - Biomet SpinalPak / OrthoPak2018-07-06 BELT EXTENSION, LARGE, SPINALPAK
00880304820852 - Biomet SpinalPak / OrthoPak2018-07-06 ELECTRODES, 63B, SPINALPAK/ORTHOPAK

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