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FDA 510(k)

METALLIC SPHERICAL CMC IMPLANT

K-Number: K960534 · 1997-02-06

ApplicantWrightmedicaltechnologyinc
Decision Date1997-02-06
Product CodeKYI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

METALLIC SPHERICAL CMC IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 1997-02-06 under 510(k) number K960534. The device is classified under product code KYI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the METALLIC SPHERICAL CMC IMPLANT?

METALLIC SPHERICAL CMC IMPLANT is a medical device that received FDA 510(k) clearance on 1997-02-06. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K960534.

When did METALLIC SPHERICAL CMC IMPLANT receive FDA 510(k) clearance?

METALLIC SPHERICAL CMC IMPLANT received FDA 510(k) clearance on 1997-02-06, under 510(k) number K960534.

Who is the listed applicant for METALLIC SPHERICAL CMC IMPLANT?

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

What is the FDA product code for METALLIC SPHERICAL CMC IMPLANT?

The FDA product code for METALLIC SPHERICAL CMC IMPLANT is KYI.

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Related Devices (Code: KYI)

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

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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