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FDA 510(k), K152041, Renaissance X System
FDA 510(k), K152041, Renaissance X System
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510(K) Number: K152041
Device Name: Renaissance X System
Manufacturer: Ayelet Matia
Device Classification Name: Orthopedic Stereotaxic Instrument
Regulation Number: OLO
Classification Product Code: 07/22/2015
Date Received: 11/17/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: Renaissance X System
Manufacturer: Ayelet Matia
Device Classification Name: Orthopedic Stereotaxic Instrument
Regulation Number: OLO
Classification Product Code: 07/22/2015
Date Received: 11/17/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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