XULTAN 5.5 REDUCTION PEDICLE SCREW 7.5 X 70 MM NON-CANN 51757000

GUDID 00819824022606

THE XULTAN 5.5 PEDICLE SCREW SYSTEM IS AN IMPLANT DEVICE MANUFACTURED FROM TITANIUM AND SILICONE. THE SCREWS ARE AVAILABLE CANNULATED OR NON-CANNULATED IN VARIOUS DIAMETERS AND LENGTHS TO ACCOMMODATE VARIOUS PATIENT ANATOMIES. THE SYSTEM INCLUDES STRAIGHT RODS, CURVED RODS, CROSSLINKS, AND ASSOCIATED INSTRUMENTATION.

MET 1 TECHNOLOGIES, LLC

Bone-screw internal spinal fixation system, sterile
Primary Device ID00819824022606
NIH Device Record Key2c902ae1-7ab6-4f34-ab3b-ffe95988084c
Commercial Distribution StatusIn Commercial Distribution
Brand NameXULTAN 5.5 REDUCTION PEDICLE SCREW 7.5 X 70 MM NON-CANN
Version Model Number51757000
Catalog Number51757000
Company DUNS080474650
Company NameMET 1 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100819824022606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

[00819824022606]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-29

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00819824028929 - 09x22x6° KODIAK PLIF TRIAL2023-10-09 The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the ve
00819824028936 - 10x22x6° KODIAK PLIF TRIAL2023-10-09 The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the ve
00819824028943 - 11x22x6° KODIAK PLIF TRIAL2023-10-09 The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the ve
00819824028950 - 12x22x6° KODIAK PLIF TRIAL2023-10-09 The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the ve
00819824028967 - 13x22x6° KODIAK PLIF TRIAL2023-10-09 The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the ve
00819824028974 - 14x22x6° KODIAK PLIF TRIAL2023-10-09 The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the ve
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