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FDA 510(k)

UNIVERSAL SELF-ALIGNING ACETABULAR COM

K-Number: K834035 · 1984-06-19

ApplicantOrthopedic Equipment Co., Inc.
Decision Date1984-06-19
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL SELF-ALIGNING ACETABULAR COM is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Equipment Co., Inc.. It received FDA 510(k) clearance on 1984-06-19 under 510(k) number K834035. 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 SELF-ALIGNING ACETABULAR COM?

UNIVERSAL SELF-ALIGNING ACETABULAR COM is a medical device that received FDA 510(k) clearance on 1984-06-19. The listed applicant is Orthopedic Equipment Co., Inc.. The 510(k) number is K834035.

When did UNIVERSAL SELF-ALIGNING ACETABULAR COM receive FDA 510(k) clearance?

UNIVERSAL SELF-ALIGNING ACETABULAR COM received FDA 510(k) clearance on 1984-06-19, under 510(k) number K834035.

Who is the listed applicant for UNIVERSAL SELF-ALIGNING ACETABULAR COM?

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

What is the FDA product code for UNIVERSAL SELF-ALIGNING ACETABULAR COM?

The FDA product code for UNIVERSAL SELF-ALIGNING ACETABULAR COM is JDI.

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Other records listing Orthopedic Equipment Co., 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.

K841189OEC/REZAIAN SPINAL FIXATORK800530SCHLEIN TRI-SURFACE ANKLEK781445SPREADERK790247TOURNIQUET TEST GAGEK790209FILTER SYSTEM, ALTNER DISPOSABLEK781446C RING CLINCHER

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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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