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FDA 510(k)

GMRS PRESS FIT STEMS WITH PUREFIX HA

K-Number: K031217 · 2003-05-23

Decision Date2003-05-23
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GMRS PRESS FIT STEMS WITH PUREFIX HA is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics. It received FDA 510(k) clearance on 2003-05-23 under 510(k) number K031217. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GMRS PRESS FIT STEMS WITH PUREFIX HA?

GMRS PRESS FIT STEMS WITH PUREFIX HA is a medical device that received FDA 510(k) clearance on 2003-05-23. The listed applicant is Howmedica Osteonics. The 510(k) number is K031217.

When did GMRS PRESS FIT STEMS WITH PUREFIX HA receive FDA 510(k) clearance?

GMRS PRESS FIT STEMS WITH PUREFIX HA received FDA 510(k) clearance on 2003-05-23, under 510(k) number K031217.

Who is the listed applicant for GMRS PRESS FIT STEMS WITH PUREFIX HA?

The FDA 510(k) record lists Howmedica Osteonics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GMRS PRESS FIT STEMS WITH PUREFIX HA?

The FDA product code for GMRS PRESS FIT STEMS WITH PUREFIX HA is LZO.

Related Clinical Trials

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.

Other records listing Howmedica Osteonics as applicant

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.

View all 13 devices →

Related Devices (Code: LZO)

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.

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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