Brainlab Compatible K2M Navigation Instruments

Orthopedic Stereotaxic Instrument

K2M

The following data is part of a premarket notification filed by K2m with the FDA for Brainlab Compatible K2m Navigation Instruments.

Pre-market Notification Details

• Device ID: K181890
• 510k Number: K181890
• Device Name: Brainlab Compatible K2M Navigation Instruments
• Classification: Orthopedic Stereotaxic Instrument
• Applicant: K2M 600 Hope Parkway SE Leesburg, VA 20175
• Contact: Nancy Giezen
• Correspondent: Nancy Giezen; K2M 600 Hope Parkway SE Leesburg, VA 20175
• Product Code: OLO
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-07-13
• Decision Date: 2018-11-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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