Cleared Traditional

K040432 - SOLAR 2 ANATOMIC SHOULDER
(FDA 510(k) Clearance)

K040432 · Stryker Orthopaedics · Orthopedic

Jan 2005

Decision

323d

Days

Class 2

Risk

K040432 is an FDA 510(k) clearance for the SOLAR 2 ANATOMIC SHOULDER, a Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (Class II — Special Controls, product code HSD), submitted by Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on January 7, 2005, 323 days after receiving the submission on February 19, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3690.

Submission Details

510(k) Number	K040432 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 19, 2004
Decision Date	January 07, 2005
Days to Decision	323 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF