ORTHOPILOT

Neurological Stereotaxic Instrument

KINAMED, INC.

The following data is part of a premarket notification filed by Kinamed, Inc. with the FDA for Orthopilot.

Pre-market Notification Details

• Device ID: K003347
• 510k Number: K003347
• Device Name: ORTHOPILOT
• Classification: Neurological Stereotaxic Instrument
• Applicant: KINAMED, INC. 9229 CRANFORD DR. Potomac, MD 20854
• Contact: Joel Slomoff
• Correspondent: Joel Slomoff; KINAMED, INC. 9229 CRANFORD DR. Potomac, MD 20854
• Product Code: HAW
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-10-25
• Decision Date: 2001-02-23