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FDA 510(k)

PRIME FEMORAL CEMENT PLUG

K-Number: K955751 · 1996-01-26

ApplicantOrthopaedic Innovations, Inc.
Decision Date1996-01-26
Product CodeLZN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PRIME FEMORAL CEMENT PLUG 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 1996-01-26 under 510(k) number K955751. The device is classified under product code LZN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIME FEMORAL CEMENT PLUG?

PRIME FEMORAL CEMENT PLUG is a medical device that received FDA 510(k) clearance on 1996-01-26. The listed applicant is Orthopaedic Innovations, Inc.. The 510(k) number is K955751.

When did PRIME FEMORAL CEMENT PLUG receive FDA 510(k) clearance?

PRIME FEMORAL CEMENT PLUG received FDA 510(k) clearance on 1996-01-26, under 510(k) number K955751.

Who is the listed applicant for PRIME FEMORAL CEMENT PLUG?

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 FEMORAL CEMENT PLUG?

The FDA product code for PRIME FEMORAL CEMENT PLUG is LZN.

Related Clinical Trials

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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 STEMSK953033PRIME CEMENTED SMALL FEMORAL STEM

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Related Devices (Code: LZN)

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.

K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker OrthopaedicsK061824TORNIER CEMENT RESTRICTORTornierK032685CEMSTOP CEMENT RESTRICTORTeknimed, S.A.K023680BIOBUCK CEMENT RESTRICTORSmith & Nephew, Inc.K011943IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTORKensey Nash Corp.K010840SYNPLUGIsotis NV

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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