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FDA 510(k)

BIPOLAR HIP SYSTEM

K-Number: K892398 · 1989-05-23

ApplicantOrthomet, Inc.
Decision Date1989-05-23
Product CodeKXA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIPOLAR HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthomet, Inc.. It received FDA 510(k) clearance on 1989-05-23 under 510(k) number K892398. 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 BIPOLAR HIP SYSTEM?

BIPOLAR HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1989-05-23. The listed applicant is Orthomet, Inc.. The 510(k) number is K892398.

When did BIPOLAR HIP SYSTEM receive FDA 510(k) clearance?

BIPOLAR HIP SYSTEM received FDA 510(k) clearance on 1989-05-23, under 510(k) number K892398.

Who is the listed applicant for BIPOLAR HIP SYSTEM?

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

What is the FDA product code for BIPOLAR HIP SYSTEM?

The FDA product code for BIPOLAR HIP SYSTEM is KXA.

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Other records listing Orthomet, 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.

K936310ORTHOMET HMC FEMORAL STEM COMPONENTK945783ORTHOMET TITANIUM HYBRID FEMORAL STEMK943873ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SYK944752ORTHOMET RESURFACING FEMORAL COMPONENTK930771PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEMK926334AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER

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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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