FDA 510(k)

GRACE DYNAMIC TORP

K-Number: K091187 · 2009-09-14

Decision Date2009-09-14

Product CodeETA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

GRACE DYNAMIC TORP is the device name listed in this FDA 510(k) record. The listed applicant is Grace Medical, Inc.. It received FDA 510(k) clearance on 2009-09-14 under 510(k) number K091187. The device is classified under product code ETA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRACE DYNAMIC TORP?

GRACE DYNAMIC TORP is a medical device that received FDA 510(k) clearance on 2009-09-14. The listed applicant is Grace Medical, Inc.. The 510(k) number is K091187.

When did GRACE DYNAMIC TORP receive FDA 510(k) clearance?

GRACE DYNAMIC TORP received FDA 510(k) clearance on 2009-09-14, under 510(k) number K091187.

Who is the listed applicant for GRACE DYNAMIC TORP?

The FDA 510(k) record lists Grace Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GRACE DYNAMIC TORP?

The FDA product code for GRACE DYNAMIC TORP is ETA.

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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.