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FDA 510(k)

Osteotomy Wedge System

K-Number: K252254 · 2025-10-17

ApplicantSinaptic Surgical
Decision Date2025-10-17
Product CodePLF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Osteotomy Wedge System is the device name listed in this FDA 510(k) record. The listed applicant is Sinaptic Surgical. It received FDA 510(k) clearance on 2025-10-17 under 510(k) number K252254. 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 Osteotomy Wedge System?

Osteotomy Wedge System is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is Sinaptic Surgical. The 510(k) number is K252254.

When did Osteotomy Wedge System receive FDA 510(k) clearance?

Osteotomy Wedge System received FDA 510(k) clearance on 2025-10-17, under 510(k) number K252254.

Who is the listed applicant for Osteotomy Wedge System?

The FDA 510(k) record lists Sinaptic Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Osteotomy Wedge System?

The FDA product code for Osteotomy Wedge System is PLF.

Related Devices (Code: PLF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252733ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLCK251791Auxano® Wedge Fixation SystemAuxano Medical, LLCK240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.K243231Trigon PEEK HA WedgesNvision Biomedical TechnologiesK234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical TechnologiesK231496TITAN 3-D Wedge SystemParagon 28, 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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