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FDA 510(k)

OPTI-FIX ACETABULAR COMPONENT

K-Number: K864857 · 1987-03-24

ApplicantRichards Medical Co., Inc.
Decision Date1987-03-24
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

OPTI-FIX ACETABULAR COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Richards Medical Co., Inc.. It received FDA 510(k) clearance on 1987-03-24 under 510(k) number K864857. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the OPTI-FIX ACETABULAR COMPONENT?

OPTI-FIX ACETABULAR COMPONENT is a medical device that received FDA 510(k) clearance on 1987-03-24. The listed applicant is Richards Medical Co., Inc.. The 510(k) number is K864857.

When did OPTI-FIX ACETABULAR COMPONENT receive FDA 510(k) clearance?

OPTI-FIX ACETABULAR COMPONENT received FDA 510(k) clearance on 1987-03-24, under 510(k) number K864857.

Who is the listed applicant for OPTI-FIX ACETABULAR COMPONENT?

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

What is the FDA product code for OPTI-FIX ACETABULAR COMPONENT?

The FDA product code for OPTI-FIX ACETABULAR COMPONENT is JDI.

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Other records listing Richards Medical 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.

K896106ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTSK900628MODULAR HIP SYSTEMK896580UNI-POLAR HEADK895241INTRAMEDULLARY HIP SCREWK884824TRICON-M TOTAL KNEE SYSTEMK896204ZIRCONIA CERAMIC HEAD ADD'L SIZES

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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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