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FDA 510(k)

ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM

K-Number: K924379 · 1993-02-12

ApplicantJohnson & Johnson Orthopaedics, Inc.
Decision Date1993-02-12
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Orthopaedics, Inc.. It received FDA 510(k) clearance on 1993-02-12 under 510(k) number K924379. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM?

ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM is a medical device that received FDA 510(k) clearance on 1993-02-12. The listed applicant is Johnson & Johnson Orthopaedics, Inc.. The 510(k) number is K924379.

When did ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM receive FDA 510(k) clearance?

ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM received FDA 510(k) clearance on 1993-02-12, under 510(k) number K924379.

Who is the listed applicant for ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM?

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

What is the FDA product code for ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM?

The FDA product code for ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM is KWL.

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Other records listing Johnson & Johnson Orthopaedics, 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.

K931466PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRIK935452P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENTK940190ULTIMA UNIPOLAR MODULAR HEADK933275P.F.C. CERAMIC HIP HEADK932595ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTORK931655P.F.C. BIPOLAR HIP SYSTEM

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Related Devices (Code: KWL)

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.

K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLCK260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementDepuy Ireland UCK253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLCK252326InterSpace GV Hip SpacerTecres S.P.A.K242865Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerBiocomposites, Ltd.K234028COPAL® exchange G hip spacer; COPAL® G+VHeraeus Medical GmbH

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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