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FDA 510(k)

MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON

K-Number: K904870 · 1991-05-23

ApplicantEndotec, Inc.
Decision Date1991-05-23
Product CodeKXA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON is the device name listed in this FDA 510(k) record. The listed applicant is Endotec, Inc.. It received FDA 510(k) clearance on 1991-05-23 under 510(k) number K904870. 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 MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON?

MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON is a medical device that received FDA 510(k) clearance on 1991-05-23. The listed applicant is Endotec, Inc.. The 510(k) number is K904870.

When did MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON receive FDA 510(k) clearance?

MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON received FDA 510(k) clearance on 1991-05-23, under 510(k) number K904870.

Who is the listed applicant for MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON?

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

What is the FDA product code for MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON?

The FDA product code for MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON is KXA.

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Other records listing Endotec, 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.

K081400FANNING-PAPPAS MODULAR KNEE BEARINGK012702BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1K992394BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENTK982418BUECHEL-PAPPAS MODULAR SALVAGE STEMK963100TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUPK963101B-P HEMISPHERICAL ACETABULAR COMPONENT

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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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