Navipro Knee Software Module

Q: What is the product code of K033668?

The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.

FDA 510(k) K033668 · Kinamed, Inc.

Substantially Equivalent

510(k) numberK033668

Submission

Device name: Navipro Knee Software Module
Applicant: Kinamed, Inc.
Camarillo, CA, US
Received: November 21, 2003
Decision date: March 11, 2004
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: HAW – Neurological Stereotaxic Instrument
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.4560
Specialty: Neurology

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Questions and answers

When was Navipro Knee Software Module cleared by the FDA?

Navipro Knee Software Module (K033668) received a 510(k) decision of Substantially Equivalent on March 11, 2004, 111 days after the submission was received.

What is the product code of K033668?

The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.