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FDA 510(k)

GROSS HIP FEMORAL COMPONENT

K-Number: K904737 · 1991-07-26

ApplicantJohnson & Johnson Orthopaedics, Inc.
Decision Date1991-07-26
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GROSS HIP FEMORAL COMPONENT 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 1991-07-26 under 510(k) number K904737. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GROSS HIP FEMORAL COMPONENT?

GROSS HIP FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 1991-07-26. The listed applicant is Johnson & Johnson Orthopaedics, Inc.. The 510(k) number is K904737.

When did GROSS HIP FEMORAL COMPONENT receive FDA 510(k) clearance?

GROSS HIP FEMORAL COMPONENT received FDA 510(k) clearance on 1991-07-26, under 510(k) number K904737.

Who is the listed applicant for GROSS HIP FEMORAL COMPONENT?

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 GROSS HIP FEMORAL COMPONENT?

The FDA product code for GROSS HIP FEMORAL COMPONENT is JDI.

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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: JDI)

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 AugmentsBiomet Orthopedics, Inc.K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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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