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FDA 510(k)

MODULAR-PLUS REVISION STEM

K-Number: K994126 · 2000-05-04

ApplicantPlus Orthopedics
Decision Date2000-05-04
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODULAR-PLUS REVISION STEM is the device name listed in this FDA 510(k) record. The listed applicant is Plus Orthopedics. It received FDA 510(k) clearance on 2000-05-04 under 510(k) number K994126. The device is classified under product code LWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODULAR-PLUS REVISION STEM?

MODULAR-PLUS REVISION STEM is a medical device that received FDA 510(k) clearance on 2000-05-04. The listed applicant is Plus Orthopedics. The 510(k) number is K994126.

When did MODULAR-PLUS REVISION STEM receive FDA 510(k) clearance?

MODULAR-PLUS REVISION STEM received FDA 510(k) clearance on 2000-05-04, under 510(k) number K994126.

Who is the listed applicant for MODULAR-PLUS REVISION STEM?

The FDA 510(k) record lists Plus Orthopedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODULAR-PLUS REVISION STEM?

The FDA product code for MODULAR-PLUS REVISION STEM is LWJ.

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Other records listing Plus Orthopedics 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.

K032126PROMOS SHOULDERK033763MODIFICATION TO SLIM GLIDING NAIL SYSTEMK032709MODULAR PLUS HIP STEMK032548IP-XS COMPRESSION NAIL SYSTEMK032215VKS/TC-PLUS REVISION KNEEK032052UC-PLUS SOLUTION UNICONDYLAR KNEE

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Related Devices (Code: LWJ)

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.

K120595UNISYN PLUS HIP STEMConsensus Orthopedics, Inc.K103518TRINITY ACETABULAR SYSTEMCorin USAK090764NOVATION CFS PRESS-FIT AND CEMENTED STEMSExactech, Inc.K082146METHA SHORT STEM HIP SYSTEM XL FEMORAL HEADAesculap Implant Systems, Inc.K07006136MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERTHayes Medical, Inc.K062978U2 HIP STEM, TI PLASMA SPRAYUnited Orthopedic Corp.

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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