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FDA 510(k)

NELSON RESURFACING HEAD

K-Number: K983452 · 1998-12-03

ApplicantBiomet, Inc.
Decision Date1998-12-03
Product CodeKXA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NELSON RESURFACING HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1998-12-03 under 510(k) number K983452. The device is classified under product code KXA. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NELSON RESURFACING HEAD?

NELSON RESURFACING HEAD is a medical device that received FDA 510(k) clearance on 1998-12-03. The listed applicant is Biomet, Inc.. The 510(k) number is K983452.

When did NELSON RESURFACING HEAD receive FDA 510(k) clearance?

NELSON RESURFACING HEAD received FDA 510(k) clearance on 1998-12-03, under 510(k) number K983452.

Who is the listed applicant for NELSON RESURFACING HEAD?

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

What is the FDA product code for NELSON RESURFACING HEAD?

The FDA product code for NELSON RESURFACING HEAD is KXA.

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Other records listing Biomet, 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.

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Related Devices (Code: KXA)

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.

K201219Biocore9 Femoral Head Resurfacing ComponentBiocore9, LLCK092198CORMET CEMENTLESS RESURFACING FEMORAL HEADCorin USAK082673CONSERVE PRESSFIT FEMORAL COMPONENTWrightmedicaltechnologyincK071053RECAP HA PRESS-FIT FEMORAL RESURFACING HEADBiomet, Inc.K070292DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTSZimmer GmbHK062960CONSERVE FEMORAL RESURFACING COMPONENTWrightmedicaltechnologyinc

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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