Preference Pedicle Screw System

GUDID 00841732151093

Cross-connector 26mm Fixed

CTL Medical Corporation

Bone-screw internal spinal fixation system connector
Primary Device ID00841732151093
NIH Device Record Keyae550f6a-4110-4e07-81a1-7c4dcfd93b85
Commercial Distribution StatusIn Commercial Distribution
Brand NamePreference Pedicle Screw System
Version Model Number10-2961-526
Company DUNS080138504
Company NameCTL Medical Corporation
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone214-545-5820
Emailschedule@ctlamedica.com
Phone214-545-5820
Emailschedule@ctlamedica.com
Phone214-545-5820
Emailschedule@ctlamedica.com
Phone214-545-5820
Emailschedule@ctlamedica.com
Phone214-545-5820
Emailschedule@ctlamedica.com
Phone214-545-5820
Emailschedule@ctlamedica.com
Phone214-545-5820
Emailschedule@ctlamedica.com
Phone214-545-5820
Emailschedule@ctlamedica.com
Phone214-545-5820
Emailschedule@ctlamedica.com
Phone214-545-5820
Emailschedule@ctlamedica.com
Phone214-545-5820
Emailschedule@ctlamedica.com
Phone214-545-5820
Emailschedule@ctlamedica.com
Phone214-545-5820
Emailschedule@ctlamedica.com
Phone214-545-5820
Emailschedule@ctlamedica.com
Phone214-545-5820
Emailschedule@ctlamedica.com
Phone214-545-5820
Emailschedule@ctlamedica.com
Phone214-545-5820
Emailschedule@ctlamedica.com
Phone214-545-5820
Emailschedule@ctlamedica.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841732151093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAppliance, Fixation, Spinal Interlaminal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841732151093]

Moist Heat or Steam Sterilization


[00841732151093]

Moist Heat or Steam Sterilization


[00841732151093]

Moist Heat or Steam Sterilization


[00841732151093]

Moist Heat or Steam Sterilization


[00841732151093]

Moist Heat or Steam Sterilization


[00841732151093]

Moist Heat or Steam Sterilization


[00841732151093]

Moist Heat or Steam Sterilization


[00841732151093]

Moist Heat or Steam Sterilization


[00841732151093]

Moist Heat or Steam Sterilization


[00841732151093]

Moist Heat or Steam Sterilization


[00841732151093]

Moist Heat or Steam Sterilization


[00841732151093]

Moist Heat or Steam Sterilization


[00841732151093]

Moist Heat or Steam Sterilization


[00841732151093]

Moist Heat or Steam Sterilization


[00841732151093]

Moist Heat or Steam Sterilization


[00841732151093]

Moist Heat or Steam Sterilization


[00841732151093]

Moist Heat or Steam Sterilization


[00841732151093]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-07
Device Publish Date2024-09-27

On-Brand Devices [Preference Pedicle Screw System]

00841732145139Connector Caddy- Fixed
00841732145122Lateral Connector Caddy
00841732145115Domino Connector Caddy
00841732151093Cross-connector 26mm Fixed
00841732151086Cross-connector 24mm Fixed
00841732151079Cross-connector 22mm Fixed
00841732151062Cross-connector 20mm Fixed
00841732151055Cross Connector 90mm Variable Length (63mm-90mm)
00841732151048Cross Connector 70mm Variable Length (51mm-70mm)
00841732151031Cross Connector 55mm Variable Length (43mm-55mm)
00841732151024Cross Connector 45mm Variable Length (37mm-45mm)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.