Spinal-Stim

GUDID 18257200078929

Spinal-Stim Bone Growth Stimulator

ORTHOFIX INC.

Patient-worn bone growth electromagnetic stimulator
Primary Device ID18257200078929
NIH Device Record Keyac605d8e-b6c9-4936-8334-ad766436c79a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpinal-Stim
Version Model Number2212
Company DUNS927083808
Company NameORTHOFIX INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.c
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.c
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS118257200078929 [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 Date2014-09-24

On-Brand Devices [Spinal-Stim]

18257200079124Spinal-Stim Bone Growth Stimulator
18257200078929Spinal-Stim Bone Growth Stimulator
18257200007127Spinal-Stim Bone Growth Stimulator
18257200007110Spinal-Stim Bone Growth Stimulator

Trademark Results [Spinal-Stim]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPINAL-STIM
SPINAL-STIM
73552537 1384143 Live/Registered
AMERICAN MEDICAL ELECTRONICS, INC.
1985-08-08

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