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FDA 510(k)

ZIRCONIA CERAMIC HEAD ADD'L SIZES

K-Number: K896204 · 1989-11-20

ApplicantRichards Medical Co., Inc.
Decision Date1989-11-20
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ZIRCONIA CERAMIC HEAD ADD'L SIZES is the device name listed in this FDA 510(k) record. The listed applicant is Richards Medical Co., Inc.. It received FDA 510(k) clearance on 1989-11-20 under 510(k) number K896204. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ZIRCONIA CERAMIC HEAD ADD'L SIZES?

ZIRCONIA CERAMIC HEAD ADD'L SIZES is a medical device that received FDA 510(k) clearance on 1989-11-20. The listed applicant is Richards Medical Co., Inc.. The 510(k) number is K896204.

When did ZIRCONIA CERAMIC HEAD ADD'L SIZES receive FDA 510(k) clearance?

ZIRCONIA CERAMIC HEAD ADD'L SIZES received FDA 510(k) clearance on 1989-11-20, under 510(k) number K896204.

Who is the listed applicant for ZIRCONIA CERAMIC HEAD ADD'L SIZES?

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

What is the FDA product code for ZIRCONIA CERAMIC HEAD ADD'L SIZES?

The FDA product code for ZIRCONIA CERAMIC HEAD ADD'L SIZES is LZO.

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Other records listing Richards Medical Co., Inc. 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.

K896106ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTSK900628MODULAR HIP SYSTEMK896580UNI-POLAR HEADK895241INTRAMEDULLARY HIP SCREWK884824TRICON-M TOTAL KNEE SYSTEMK895242PAPPAS TRI-FLANGE VENTILATION TUBE

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Related Devices (Code: LZO)

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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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