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FDA 510(k)

CEMENTED FEMORAL HEAD RESURFING DEVICE

K-Number: K021799 · 2002-06-26

ApplicantBiomet Orthopedics, Inc.
Decision Date2002-06-26
Product CodeKXA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CEMENTED FEMORAL HEAD RESURFING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Orthopedics, Inc.. It received FDA 510(k) clearance on 2002-06-26 under 510(k) number K021799. 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 CEMENTED FEMORAL HEAD RESURFING DEVICE?

CEMENTED FEMORAL HEAD RESURFING DEVICE is a medical device that received FDA 510(k) clearance on 2002-06-26. The listed applicant is Biomet Orthopedics, Inc.. The 510(k) number is K021799.

When did CEMENTED FEMORAL HEAD RESURFING DEVICE receive FDA 510(k) clearance?

CEMENTED FEMORAL HEAD RESURFING DEVICE received FDA 510(k) clearance on 2002-06-26, under 510(k) number K021799.

Who is the listed applicant for CEMENTED FEMORAL HEAD RESURFING DEVICE?

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

What is the FDA product code for CEMENTED FEMORAL HEAD RESURFING DEVICE?

The FDA product code for CEMENTED FEMORAL HEAD RESURFING DEVICE is KXA.

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Other records listing Biomet Orthopedics, 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.

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsK080528E-POLY TIBIAL BEARINGSK072879INNERVUE DIAGNOSTIC SCOPE SYSTEMK070955ACID ETCHED LAG SCREWSK033355LACTOSCREW SCREW ANCHORK032286CALCIGEN PSI BONE GRAFT SUBSTITUTE

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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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