SPINAL STIM 655212-0001

GUDID 18257200105670

Osteogenesis Stimulator, SPININAL STIM US

ORTHOFIX INC.

Patient-worn bone growth electromagnetic stimulator
Primary Device ID18257200105670
NIH Device Record Key3c3d3024-118f-448e-b22c-845b2f1211c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPINAL STIM
Version Model Number5212
Catalog Number655212-0001
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 Datetrue
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 HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS118257200105670 [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 Date2017-01-23

On-Brand Devices [SPINAL STIM]

18257200105687Osteogenesis Stimulator SPINAL STIM US DEMO
18257200105670Osteogenesis Stimulator, SPININAL STIM US

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