XULTAN 5.5 REDUCTION PEDICLE SCREW 8.5 X 90 MM NON- CANN 51859000

GUDID 00819824022903

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 Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 00819824022903
• NIH Device Record Key: 84e45679-3e6e-40d7-81f0-cb441d0c0806
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XULTAN 5.5 REDUCTION PEDICLE SCREW 8.5 X 90 MM NON- CANN
• Version Model Number: 51859000
• Catalog Number: 51859000
• Company DUNS: 080474650
• Company Name: MET 1 TECHNOLOGIES, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9154726762
• Email: yone@met1tech.com
• Phone: 9154726762
• Email: yone@met1tech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819824022903 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170108

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00819824022903]

Moist Heat or Steam Sterilization

[00819824022903]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-29

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