Perseus

Orthopedic Stereotaxic Instrument

Orthokey Italia S.r.l.

The following data is part of a premarket notification filed by Orthokey Italia S.r.l. with the FDA for Perseus.

Pre-market Notification Details

• Device ID: K192653
• 510k Number: K192653
• Device Name: Perseus
• Classification: Orthopedic Stereotaxic Instrument
• Applicant: Orthokey Italia S.r.l. Piazza Nazioni Unite, 15 Carrara, IT 54033
• Contact: Cristiano Paggetti
• Correspondent: Guido Bonapace; Isemed Srl Via P. Togliatti, 19/X Imola, IT 40026
• Product Code: OLO
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-09-24
• Decision Date: 2020-09-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08052675960013	K192653	000
08052675960167	K192653	000
08052675960044	K192653	000
08052675960068	K192653	000
08052675960082	K192653	000
08052675960099	K192653	000
08052675960105	K192653	000
08052675960112	K192653	000
08052675960174	K192653	000
08052675960181	K192653	000
08052675960198	K192653	000
08052675960204	K192653	000
08052675960020	K192653	000
08052675960037	K192653	000
08052675960051	K192653	000
08052675960143	K192653	000