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FDA 510(k)

PARTIAL OSSICULAR REPLACEMENT PROSTHESES

K-Number: K060518 · 2006-06-28

ApplicantGrace Medical, Inc.
Decision Date2006-06-28
Product CodeETB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PARTIAL OSSICULAR REPLACEMENT PROSTHESES 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 2006-06-28 under 510(k) number K060518. The device is classified under product code ETB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARTIAL OSSICULAR REPLACEMENT PROSTHESES?

PARTIAL OSSICULAR REPLACEMENT PROSTHESES is a medical device that received FDA 510(k) clearance on 2006-06-28. The listed applicant is Grace Medical, Inc.. The 510(k) number is K060518.

When did PARTIAL OSSICULAR REPLACEMENT PROSTHESES receive FDA 510(k) clearance?

PARTIAL OSSICULAR REPLACEMENT PROSTHESES received FDA 510(k) clearance on 2006-06-28, under 510(k) number K060518.

Who is the listed applicant for PARTIAL OSSICULAR REPLACEMENT PROSTHESES?

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 PARTIAL OSSICULAR REPLACEMENT PROSTHESES?

The FDA product code for PARTIAL OSSICULAR REPLACEMENT PROSTHESES is ETB.

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Related Devices (Code: ETB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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