Cleared Traditional

ADAPT for Gamma3

K202749 · Stryker GmbH · Orthopedic
Dec 2020
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K202749 is an FDA 510(k) clearance for the ADAPT for Gamma3, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Stryker GmbH (Malwah, US). The FDA issued a Cleared decision on December 18, 2020, 88 days after receiving the submission on September 21, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K202749 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2020
Decision Date December 18, 2020
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code OLO — Orthopedic Stereotaxic Instrument
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.

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