Cleared Traditional

K210998 - ROSA Hip System (FDA 510(k) Clearance)

K210998 · Orthosoft D/B/A Zimmer Cas · Radiology device

Aug 2021

Decision

137d

Days

Class 2

Risk

K210998 is an FDA 510(k) clearance for the ROSA Hip System. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Orthosoft D/B/A Zimmer Cas (Montreal, CA). The FDA issued a Cleared decision on August 17, 2021, 137 days after receiving the submission on April 2, 2021.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K210998 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 02, 2021
Decision Date	August 17, 2021
Days to Decision	137 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF