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FDA 510(k)

Robotic Graft Delivery Instruments

K-Number: K230716 · 2023-07-18

ApplicantMedtronic Sofamor Danek, Inc.
Decision Date2023-07-18
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Robotic Graft Delivery Instruments is a medical device manufactured by Medtronic Sofamor Danek, Inc.. It received FDA 510(k) clearance on 2023-07-18 under approval number K230716. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Robotic Graft Delivery Instruments?

Robotic Graft Delivery Instruments is a medical device that received FDA 510(k) clearance on 2023-07-18. It is manufactured by Medtronic Sofamor Danek, Inc.. The 510(k) number is K230716.

When was Robotic Graft Delivery Instruments approved by the FDA?

Robotic Graft Delivery Instruments received FDA 510(k) clearance on 2023-07-18, under approval number K230716.

What company makes Robotic Graft Delivery Instruments?

Robotic Graft Delivery Instruments is manufactured by Medtronic Sofamor Danek, Inc..

What is the FDA product code for Robotic Graft Delivery Instruments?

The FDA product code for Robotic Graft Delivery Instruments is OLO.

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Other Devices by Medtronic Sofamor Danek, Inc.

K251193Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules PMA P060018Prosthesis, intervertebral disc

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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