ROSA ONE Spine Application

Orthopedic Stereotaxic Instrument

Medtech S.A.

The following data is part of a premarket notification filed by Medtech S.a. with the FDA for Rosa One Spine Application.

Pre-market Notification Details

• Device ID: K182848
• 510k Number: K182848
• Device Name: ROSA ONE Spine Application
• Classification: Orthopedic Stereotaxic Instrument
• Applicant: Medtech S.A. ZAC Eureka - 900 Rue Du Mas De Verchant Montpellier, FR 34000
• Contact: Serge Tabet
• Correspondent: Serge Tabet; Medtech S.A. ZAC Eureka - 900 Rue Du Mas De Verchant Montpellier, FR 34000
• Product Code: OLO
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-10-09
• Decision Date: 2019-03-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03760244034106	K182848	000
03760244033482	K182848	000
03760244033475	K182848	000
03760244032164	K182848	000
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03760244032232	K182848	000
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03760244032300	K182848	000