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FDA 510(k)

TITAN 3-D Wedge System

K-Number: K231496 · 2023-08-22

ApplicantParagon 28, Inc.
Decision Date2023-08-22
Product CodePLF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TITAN 3-D Wedge System is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2023-08-22 under approval number K231496. The device is classified under product code PLF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TITAN 3-D Wedge System?

TITAN 3-D Wedge System is a medical device that received FDA 510(k) clearance on 2023-08-22. It is manufactured by Paragon 28, Inc.. The 510(k) number is K231496.

When was TITAN 3-D Wedge System approved by the FDA?

TITAN 3-D Wedge System received FDA 510(k) clearance on 2023-08-22, under approval number K231496.

What company makes TITAN 3-D Wedge System?

TITAN 3-D Wedge System is manufactured by Paragon 28, Inc..

What is the FDA product code for TITAN 3-D Wedge System?

The FDA product code for TITAN 3-D Wedge System is PLF.

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Related Devices (Code: PLF)

K171327Tyber Medical Wedge SystemTyber Medical, LLC K162241TITAN 3-D™ Wedge SystemParagon 28 K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. K191047ADI TiDAL Osteotomy WedgeAdditive Device, Inc. (Adi) D/B/A Restor3D K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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