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FDA 510(k)

OSSEOSPEED 4.0S-6MM, MODEL 24619

K-Number: K063779 · 2007-04-27

ApplicantAstra Tech, Inc.
Decision Date2007-04-27
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSSEOSPEED 4.0S-6MM, MODEL 24619 is the device name listed in this FDA 510(k) record. The listed applicant is Astra Tech, Inc.. It received FDA 510(k) clearance on 2007-04-27 under 510(k) number K063779. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSSEOSPEED 4.0S-6MM, MODEL 24619?

OSSEOSPEED 4.0S-6MM, MODEL 24619 is a medical device that received FDA 510(k) clearance on 2007-04-27. The listed applicant is Astra Tech, Inc.. The 510(k) number is K063779.

When did OSSEOSPEED 4.0S-6MM, MODEL 24619 receive FDA 510(k) clearance?

OSSEOSPEED 4.0S-6MM, MODEL 24619 received FDA 510(k) clearance on 2007-04-27, under 510(k) number K063779.

Who is the listed applicant for OSSEOSPEED 4.0S-6MM, MODEL 24619?

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

What is the FDA product code for OSSEOSPEED 4.0S-6MM, MODEL 24619?

The FDA product code for OSSEOSPEED 4.0S-6MM, MODEL 24619 is DZE.

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Other records listing Astra Tech, Inc. as applicant

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Related Devices (Code: DZE)

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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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