MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM

Orthopedic Stereotaxic Instrument

MAKO SURGICAL CORPORATION

The following data is part of a premarket notification filed by Mako Surgical Corporation with the FDA for Makoplasty Total Hip Application, Rio Standard System.

Pre-market Notification Details

• Device ID: K121064
• 510k Number: K121064
• Device Name: MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM
• Classification: Orthopedic Stereotaxic Instrument
• Applicant: MAKO SURGICAL CORPORATION 2555 DAVIE ROAD Fort Lauderdale, FL 33317
• Contact: Dionne Sanders
• Correspondent: Dionne Sanders; MAKO SURGICAL CORPORATION 2555 DAVIE ROAD Fort Lauderdale, FL 33317
• Product Code: OLO
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-04-06
• Decision Date: 2012-06-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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