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FDA 510(k)

LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT

K-Number: K883212 · 1988-11-22

ApplicantImplant Technology, Inc.
Decision Date1988-11-22
Product CodeKXA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Implant Technology, Inc.. It received FDA 510(k) clearance on 1988-11-22 under 510(k) number K883212. 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 LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT?

LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT is a medical device that received FDA 510(k) clearance on 1988-11-22. The listed applicant is Implant Technology, Inc.. The 510(k) number is K883212.

When did LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT receive FDA 510(k) clearance?

LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT received FDA 510(k) clearance on 1988-11-22, under 510(k) number K883212.

Who is the listed applicant for LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT?

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

What is the FDA product code for LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT?

The FDA product code for LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT is KXA.

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Other records listing Implant Technology, 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.

K921525HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESISK915617LSF HA COATED FEMORAL HIPK920021LSF TOTAL HIP SYSTEM - MULLER-TYPE ACETABULAR CUPK913616LSF DIAGNOSTIC RELATED GROUP CEMENTED HIPK902727LSF CEMENTED FEMORAL HIPK901460LSF(TM) TOTAL HIP SYSTEM

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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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