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FDA 510(k)

PRIME CEMENTED HIP SYSTEM

K-Number: K940328 · 1995-04-07

ApplicantOrthopaedic Innovations, Inc.
Decision Date1995-04-07
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

PRIME CEMENTED HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthopaedic Innovations, Inc.. It received FDA 510(k) clearance on 1995-04-07 under 510(k) number K940328. 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 PRIME CEMENTED HIP SYSTEM?

PRIME CEMENTED HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1995-04-07. The listed applicant is Orthopaedic Innovations, Inc.. The 510(k) number is K940328.

When did PRIME CEMENTED HIP SYSTEM receive FDA 510(k) clearance?

PRIME CEMENTED HIP SYSTEM received FDA 510(k) clearance on 1995-04-07, under 510(k) number K940328.

Who is the listed applicant for PRIME CEMENTED HIP SYSTEM?

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

What is the FDA product code for PRIME CEMENTED HIP SYSTEM?

The FDA product code for PRIME CEMENTED HIP SYSTEM is JDI.

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Other records listing Orthopaedic Innovations, 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.

K020145ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEMK983881COBRA EXTERNAL FIXATORK962646PRIME MODULAR ENDO HEADK960014PRACTIFIX EXTERNAL FIXATION SYSTEMK955620PRIME CEMENTED CALCAR FEMORAL STEMSK955751PRIME FEMORAL CEMENT PLUG

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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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