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FDA 510(k)

DAC Dynamic Active Compression Plate

K-Number: K200513 · 2020-07-22

ApplicantPioneer Surgical Technology, Inc., Dba Rti Surgical
Decision Date2020-07-22
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DAC Dynamic Active Compression Plate is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology, Inc., Dba Rti Surgical. It received FDA 510(k) clearance on 2020-07-22 under 510(k) number K200513. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DAC Dynamic Active Compression Plate?

DAC Dynamic Active Compression Plate is a medical device that received FDA 510(k) clearance on 2020-07-22. The listed applicant is Pioneer Surgical Technology, Inc., Dba Rti Surgical. The 510(k) number is K200513.

When did DAC Dynamic Active Compression Plate receive FDA 510(k) clearance?

DAC Dynamic Active Compression Plate received FDA 510(k) clearance on 2020-07-22, under 510(k) number K200513.

Who is the listed applicant for DAC Dynamic Active Compression Plate?

The FDA 510(k) record lists Pioneer Surgical Technology, Inc., Dba Rti Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DAC Dynamic Active Compression Plate?

The FDA product code for DAC Dynamic Active Compression Plate is HRS.

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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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