Cleared Traditional

SUBTALAR PEG IMPLANT

K033046 · Nexa Orthopedics, Inc. · Orthopedic

Dec 2003

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K033046 is an FDA 510(k) clearance for the SUBTALAR PEG IMPLANT, a Prosthesis, Subtalar, Plug, Polymer (Class II — Special Controls, product code MJW), submitted by Nexa Orthopedics, Inc. (Vista, US). The FDA issued a Cleared decision on December 23, 2003, 85 days after receiving the submission on September 29, 2003. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K033046 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2003
Decision Date	December 23, 2003
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF