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FDA 510(k)

PRIME CEMENTED CALCAR FEMORAL STEMS

K-Number: K955620 · 1996-02-20

ApplicantOrthopaedic Innovations, Inc.
Decision Date1996-02-20
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRIME CEMENTED CALCAR FEMORAL STEMS 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 1996-02-20 under 510(k) number K955620. 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 PRIME CEMENTED CALCAR FEMORAL STEMS?

PRIME CEMENTED CALCAR FEMORAL STEMS is a medical device that received FDA 510(k) clearance on 1996-02-20. The listed applicant is Orthopaedic Innovations, Inc.. The 510(k) number is K955620.

When did PRIME CEMENTED CALCAR FEMORAL STEMS receive FDA 510(k) clearance?

PRIME CEMENTED CALCAR FEMORAL STEMS received FDA 510(k) clearance on 1996-02-20, under 510(k) number K955620.

Who is the listed applicant for PRIME CEMENTED CALCAR FEMORAL STEMS?

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 CALCAR FEMORAL STEMS?

The FDA product code for PRIME CEMENTED CALCAR FEMORAL STEMS 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 SYSTEMK955751PRIME FEMORAL CEMENT PLUGK953033PRIME CEMENTED SMALL FEMORAL STEM

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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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