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FDA 510(k)

Tyber Medical Wedge System

K-Number: K171327 · 2017-05-16

ApplicantTyber Medical, LLC
Decision Date2017-05-16
Product CodePLF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tyber Medical Wedge System is a medical device manufactured by Tyber Medical, LLC. It received FDA 510(k) clearance on 2017-05-16 under approval number K171327. 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 Tyber Medical Wedge System?

Tyber Medical Wedge System is a medical device that received FDA 510(k) clearance on 2017-05-16. It is manufactured by Tyber Medical, LLC. The 510(k) number is K171327.

When was Tyber Medical Wedge System approved by the FDA?

Tyber Medical Wedge System received FDA 510(k) clearance on 2017-05-16, under approval number K171327.

What company makes Tyber Medical Wedge System?

Tyber Medical Wedge System is manufactured by Tyber Medical, LLC.

What is the FDA product code for Tyber Medical Wedge System?

The FDA product code for Tyber Medical Wedge System is PLF.

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Tyber Medical, LLC

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Related Devices (Code: PLF)

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. K201314Restor3d Utility WedgeRestor3D, 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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