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FDA 510(k)

UNIVERSAL CEMENTED CUP

K-Number: K894249 · 1989-08-03

ApplicantOrthopedic Systems, Inc.
Decision Date1989-08-03
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL CEMENTED CUP is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Systems, Inc.. It received FDA 510(k) clearance on 1989-08-03 under 510(k) number K894249. 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 UNIVERSAL CEMENTED CUP?

UNIVERSAL CEMENTED CUP is a medical device that received FDA 510(k) clearance on 1989-08-03. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K894249.

When did UNIVERSAL CEMENTED CUP receive FDA 510(k) clearance?

UNIVERSAL CEMENTED CUP received FDA 510(k) clearance on 1989-08-03, under 510(k) number K894249.

Who is the listed applicant for UNIVERSAL CEMENTED CUP?

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

What is the FDA product code for UNIVERSAL CEMENTED CUP?

The FDA product code for UNIVERSAL CEMENTED CUP is JDI.

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Other records listing Orthopedic Systems, 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.

K952495ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEMK920256SPINE MOTION ANALYZER WITH EMGK910736JACKSON MULTIPURPOSE OPERATING TABLEK910031PARK CITY SHOULDER POSITIONERK903938C FIT CUPK892503NUFFIELD TOTAL KNEE

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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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