Orthors

GUDID B030ORT5535C0

Ø5.5mm Cannulated Polyaxial Pedicle Screw, 35mm Lg.

CAMBER SPINE TECHNOLOGIES, LLC

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDB030ORT5535C0
NIH Device Record Keydbdf3e92-34bc-46a2-8d3b-8c479a425482
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthors
Version Model NumberORT-5535C
Company DUNS054205979
Company NameCAMBER SPINE TECHNOLOGIES, LLC
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 Usetrue
Lot Batchtrue
Serial Numberfalse
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

Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com

Device Dimensions

Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB030ORT5535C0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B030ORT5535C0]

Moist Heat or Steam Sterilization


[B030ORT5535C0]

Moist Heat or Steam Sterilization


[B030ORT5535C0]

Moist Heat or Steam Sterilization


[B030ORT5535C0]

Moist Heat or Steam Sterilization


[B030ORT5535C0]

Moist Heat or Steam Sterilization


[B030ORT5535C0]

Moist Heat or Steam Sterilization


[B030ORT5535C0]

Moist Heat or Steam Sterilization


[B030ORT5535C0]

Moist Heat or Steam Sterilization


[B030ORT5535C0]

Moist Heat or Steam Sterilization


[B030ORT5535C0]

Moist Heat or Steam Sterilization


[B030ORT5535C0]

Moist Heat or Steam Sterilization


[B030ORT5535C0]

Moist Heat or Steam Sterilization


[B030ORT5535C0]

Moist Heat or Steam Sterilization


[B030ORT5535C0]

Moist Heat or Steam Sterilization


[B030ORT5535C0]

Moist Heat or Steam Sterilization


[B030ORT5535C0]

Moist Heat or Steam Sterilization


[B030ORT5535C0]

Moist Heat or Steam Sterilization


[B030ORT5535C0]

Moist Heat or Steam Sterilization


[B030ORT5535C0]

Moist Heat or Steam Sterilization


[B030ORT5535C0]

Moist Heat or Steam Sterilization


[B030ORT5535C0]

Moist Heat or Steam Sterilization


[B030ORT5535C0]

Moist Heat or Steam Sterilization


[B030ORT5535C0]

Moist Heat or Steam Sterilization


[B030ORT5535C0]

Moist Heat or Steam Sterilization


[B030ORT5535C0]

Moist Heat or Steam Sterilization


[B030ORT5535C0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-05
Device Publish Date2019-01-18

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B030EZO5020050 - Enza-O2024-07-30 8° Trial Caddy Body
B030EZO5020060 - Enza-O2024-07-30 15° Trial Caddy Body
B030EZO5030010 - Enza-O2024-07-30 8°, 26mm x 32mm Caddy Lid
B030EZO5030020 - Enza-O2024-07-30 8°, 30mm x 38mm Caddy Lid
B030EZO5030030 - Enza-O2024-07-30 15°, 26mm x 32mm Caddy Lid

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