Osteotomy Wedge System— 510(k) K252254

Substantially Equivalent

Sinaptic Surgical

FDA 510(k) clearance K252254 for Osteotomy Wedge System, Substantially Equivalent on 2025-10-17. Applicant: Sinaptic Surgical. Device class: 2.

Clearance details

Applicant: Sinaptic Surgical
Product code: Code PLF
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2025-07-21
Decision date: 2025-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Slat Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PLF

K252733 — ATLAS Expandable Osteotomy Wedge System2026-02-19
K251791 — Auxano® Wedge Fixation System2025-09-25
K240461 — OsteoSinter® EVANS and COTTON wedges and related accessories2024-12-06
K243231 — Trigon PEEK HA Wedges2024-11-08
K234116 — Trigon Trigon HA Stand-Alone Wedge Fixation System2024-01-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.