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FDA 510(k)

K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES

K-Number: K080070 · 2008-04-17

ApplicantGrace Medical, Inc.
Decision Date2008-04-17
Product CodeETB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

K-HELIX PISTON AND PORP 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 2008-04-17 under 510(k) number K080070. 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 K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES?

K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES is a medical device that received FDA 510(k) clearance on 2008-04-17. The listed applicant is Grace Medical, Inc.. The 510(k) number is K080070.

When did K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES receive FDA 510(k) clearance?

K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES received FDA 510(k) clearance on 2008-04-17, under 510(k) number K080070.

Who is the listed applicant for K-HELIX PISTON AND PORP 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 K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES?

The FDA product code for K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES is ETB.

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Related Devices (Code: ETB)

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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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