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FDA 510(k)

ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS

K-Number: K924115 · 1992-11-24

ApplicantJohnson & Johnson Orthopaedics, Inc.
Decision Date1992-11-24
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS 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 1992-11-24 under 510(k) number K924115. 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 ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS?

ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS is a medical device that received FDA 510(k) clearance on 1992-11-24. The listed applicant is Johnson & Johnson Orthopaedics, Inc.. The 510(k) number is K924115.

When did ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS receive FDA 510(k) clearance?

ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS received FDA 510(k) clearance on 1992-11-24, under 510(k) number K924115.

Who is the listed applicant for ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS?

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 ALL UHMWPE CEMENTED ACETABULAR CUPS?

The FDA product code for ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS 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.

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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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