PEMF - SPINAL-STIM 5212CE

GUDID 18257200105694

5212CE, SHIP ASSY., OSTEOGENESIS STIMULATOR, SPINAL-STIM, OUS

ORTHOFIX INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID18257200105694
NIH Device Record Key7280b845-eb92-4045-946f-ecbe4b68cbc2
Commercial Distribution StatusIn Commercial Distribution
Brand NamePEMF - SPINAL-STIM
Version Model Number655212-0003
Catalog Number5212CE
Company DUNS927083808
Company NameORTHOFIX INC.
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS118257200105694 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LOFStimulator, bone growth, non-invasive

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18257200105694]

Moist Heat or Steam Sterilization


[18257200105694]

Moist Heat or Steam Sterilization


[18257200105694]

Moist Heat or Steam Sterilization


[18257200105694]

Moist Heat or Steam Sterilization


[18257200105694]

Moist Heat or Steam Sterilization


[18257200105694]

Moist Heat or Steam Sterilization


[18257200105694]

Moist Heat or Steam Sterilization


[18257200105694]

Moist Heat or Steam Sterilization


[18257200105694]

Moist Heat or Steam Sterilization


[18257200105694]

Moist Heat or Steam Sterilization


[18257200105694]

Moist Heat or Steam Sterilization


[18257200105694]

Moist Heat or Steam Sterilization


[18257200105694]

Moist Heat or Steam Sterilization


[18257200105694]

Moist Heat or Steam Sterilization


[18257200105694]

Moist Heat or Steam Sterilization


[18257200105694]

Moist Heat or Steam Sterilization


[18257200105694]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-07
Device Publish Date2020-01-30

On-Brand Devices [PEMF - SPINAL-STIM]

18257200133116SUSPENDER, SPINAL STIM 5212/2212, ACCESSORY
182572001239265212CMD, DEMO, SHIP ASSY., OSTEOGENESIS STIMULATOR, SPINAL-STIM, CM
182572001239025212CM, SHIP ASSY., OSTEOGENESIS STIMULATOR, SPINAL-STIM, CM
182572001057005212CED, DEMO, OSTEOGENESIS STIMULATOR, SPINAL-STIM, OUS
182572001056945212CE, SHIP ASSY., OSTEOGENESIS STIMULATOR, SPINAL-STIM, OUS

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