NuVasive Navigation.S Instruments

Orthopedic Stereotaxic Instrument

NuVasive, Incorporated

The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Navigation.s Instruments.

Pre-market Notification Details

• Device ID: K200719
• 510k Number: K200719
• Device Name: NuVasive Navigation.S Instruments
• Classification: Orthopedic Stereotaxic Instrument
• Applicant: NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121
• Contact: Adan Alfaro
• Correspondent: Adan Alfaro; NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121
• Product Code: OLO
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-03-19
• Decision Date: 2020-12-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00195377163493	K200719	000
00195377026149	K200719	000
00195377026156	K200719	000
00195377026170	K200719	000
00195377026187	K200719	000
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00887517059598	K200719	000