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FDA 510(k), K182121, CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition
FDA 510(k), K182121, CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition
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510(K) Number: K182121
Device Name: CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition
Manufacturer: Erikka Edwardsen
Device Classification Name: Orthopedic Stereotaxic Instrument
Regulation Number: OLO
Classification Product Code: 08/06/2018
Date Received: 11/02/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition
Manufacturer: Erikka Edwardsen
Device Classification Name: Orthopedic Stereotaxic Instrument
Regulation Number: OLO
Classification Product Code: 08/06/2018
Date Received: 11/02/2018
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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