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FDA 510(k), K182848, ROSA ONE Spine application
FDA 510(k), K182848, ROSA ONE Spine application
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510(K) Number: K182848
Device Name: ROSA ONE Spine application
Manufacturer: Serge Tabet
Device Classification Name: Orthopedic Stereotaxic Instrument
Regulation Number: OLO
Classification Product Code: KXA
Date Received: 10/09/2018
Decision Date: 03/22/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: ROSA ONE Spine application
Manufacturer: Serge Tabet
Device Classification Name: Orthopedic Stereotaxic Instrument
Regulation Number: OLO
Classification Product Code: KXA
Date Received: 10/09/2018
Decision Date: 03/22/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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