NekSpine System, w/ Extra Large Support

GUDID 00810105030570

The NekSpine is intended for relief of back and neck pain, when looking down for extended periods of time, by providing a force that counteracts the effects of gravity on the head. The device is reusable and intended for short-term use

COMPOSITE MANUFACTURING, INC.

Thoracic spine orthosis Thoracic spine orthosis Thoracic spine orthosis Thoracic spine orthosis Thoracic spine orthosis Thoracic spine orthosis Thoracic spine orthosis Thoracic spine orthosis Thoracic spine orthosis Thoracic spine orthosis Thoracic spine orthosis Thoracic spine orthosis Thoracic spine orthosis Thoracic spine orthosis Thoracic spine orthosis Thoracic spine orthosis Thoracic spine orthosis
Primary Device ID00810105030570
NIH Device Record Key9e27a2fc-0cfc-44ed-918d-3fc6328994da
Commercial Distribution StatusIn Commercial Distribution
Brand NameNekSpine System, w/ Extra Large Support
Version Model Number1-1011-007
Company DUNS947090650
Company NameCOMPOSITE MANUFACTURING, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9493617580
Emailinfo@carbonfiber.com
Phone9493617580
Emailinfo@carbonfiber.com
Phone9493617580
Emailinfo@carbonfiber.com
Phone9493617580
Emailinfo@carbonfiber.com
Phone9493617580
Emailinfo@carbonfiber.com
Phone9493617580
Emailinfo@carbonfiber.com
Phone9493617580
Emailinfo@carbonfiber.com
Phone9493617580
Emailinfo@carbonfiber.com
Phone9493617580
Emailinfo@carbonfiber.com
Phone9493617580
Emailinfo@carbonfiber.com
Phone9493617580
Emailinfo@carbonfiber.com
Phone9493617580
Emailinfo@carbonfiber.com
Phone9493617580
Emailinfo@carbonfiber.com
Phone9493617580
Emailinfo@carbonfiber.com
Phone9493617580
Emailinfo@carbonfiber.com
Phone9493617580
Emailinfo@carbonfiber.com
Phone9493617580
Emailinfo@carbonfiber.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810105030570 [Primary]

FDA Product Code

IPTOrthosis, Thoracic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-25
Device Publish Date2023-08-17

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