Cleared Traditional

SUBTALAR ARTHRORISIS IMPLANT

K032902 · Nexa Orthopedics, Inc. · Orthopedic

Dec 2003

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K032902 is an FDA 510(k) clearance for the SUBTALAR ARTHRORISIS IMPLANT, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Nexa Orthopedics, Inc. (Vista, US). The FDA issued a Cleared decision on December 15, 2003, 89 days after receiving the submission on September 17, 2003. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K032902 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 17, 2003
Decision Date	December 15, 2003
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF