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FDA 510(k)

PARADIGM FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM

K-Number: K931423 · 1994-10-13

ApplicantOrthomed
Decision Date1994-10-13
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

PARADIGM FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthomed. It received FDA 510(k) clearance on 1994-10-13 under 510(k) number K931423. The device is classified under product code LWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the PARADIGM FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM?

PARADIGM FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1994-10-13. The listed applicant is Orthomed. The 510(k) number is K931423.

When did PARADIGM FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM receive FDA 510(k) clearance?

PARADIGM FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM received FDA 510(k) clearance on 1994-10-13, under 510(k) number K931423.

Who is the listed applicant for PARADIGM FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM?

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

What is the FDA product code for PARADIGM FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM?

The FDA product code for PARADIGM FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM is LWJ.

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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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