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 a medical device manufactured by Sinaptic Surgical. It received FDA 510(k) clearance on 2025-10-17 under approval 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. It is manufactured by Sinaptic Surgical. The 510(k) number is K252254.
When was Osteotomy Wedge System approved by the FDA?
Osteotomy Wedge System received FDA 510(k) clearance on 2025-10-17, under approval number K252254.
What company makes Osteotomy Wedge System?
Osteotomy Wedge System is manufactured by Sinaptic Surgical.
What is the FDA product code for Osteotomy Wedge System?
The FDA product code for Osteotomy Wedge System is PLF.
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K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.
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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.