Stablyx CMC Arthroplasty Implant System— 510(k) K180744

Name: FDA 510(k) clearance K180744
Creator: U.S. Food and Drug Administration
Published: 2018-04-11

Substantially Equivalent

Skeletal Dynamics, LLC

FDA 510(k) clearance K180744 for Stablyx CMC Arthroplasty Implant System, Substantially Equivalent on 2018-04-11. Applicant: Skeletal Dynamics, LLC. Device class: 2.

Clearance details

Applicant: Skeletal Dynamics, LLC
Product code: Code KYI
Device class: Class 2
Regulation: 21 CFR 888.3770
Advisory panel: Orthopedic
Date received: 2018-03-22
Decision date: 2018-04-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KYI

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K201072 — Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 1612020-12-02
K111068 — STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 52011-12-30
K112278 — ASCENSION NUGRIP CMC IMPLANT2011-11-04
K092548 — EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS2009-12-15
K061956 — ARTELON STT SPACER2007-06-07

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