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FDA 510(k)

Surgical Drills

K-Number: K200265 · 2020-06-30

Decision Date2020-06-30
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Surgical Drills is a medical device manufactured by Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2020-06-30 under approval number K200265. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surgical Drills?

Surgical Drills is a medical device that received FDA 510(k) clearance on 2020-06-30. It is manufactured by Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K200265.

When was Surgical Drills approved by the FDA?

Surgical Drills received FDA 510(k) clearance on 2020-06-30, under approval number K200265.

What company makes Surgical Drills?

Surgical Drills is manufactured by Implant Direct Sybron Manufacturing, LLC.

What is the FDA product code for Surgical Drills?

The FDA product code for Surgical Drills is DZI.

Other Devices by Implant Direct Sybron Manufacturing, LLC

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Related Devices (Code: DZI)

Official Source

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