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FDA 510(k)

PERFECTA TOTAL HIP SYSTEM, HA COATED

K-Number: K915190 · 1992-12-24

ApplicantOrthomet, Inc.
Decision Date1992-12-24
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PERFECTA TOTAL HIP SYSTEM, HA COATED is the device name listed in this FDA 510(k) record. The listed applicant is Orthomet, Inc.. It received FDA 510(k) clearance on 1992-12-24 under 510(k) number K915190. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERFECTA TOTAL HIP SYSTEM, HA COATED?

PERFECTA TOTAL HIP SYSTEM, HA COATED is a medical device that received FDA 510(k) clearance on 1992-12-24. The listed applicant is Orthomet, Inc.. The 510(k) number is K915190.

When did PERFECTA TOTAL HIP SYSTEM, HA COATED receive FDA 510(k) clearance?

PERFECTA TOTAL HIP SYSTEM, HA COATED received FDA 510(k) clearance on 1992-12-24, under 510(k) number K915190.

Who is the listed applicant for PERFECTA TOTAL HIP SYSTEM, HA COATED?

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

What is the FDA product code for PERFECTA TOTAL HIP SYSTEM, HA COATED?

The FDA product code for PERFECTA TOTAL HIP SYSTEM, HA COATED is MEH.

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Other records listing Orthomet, 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.

K936310ORTHOMET HMC FEMORAL STEM COMPONENTK945783ORTHOMET TITANIUM HYBRID FEMORAL STEMK943873ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SYK944752ORTHOMET RESURFACING FEMORAL COMPONENTK930771PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEMK926334AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER

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Related Devices (Code: MEH)

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.

K261576Icona Hip StemCorin, Ltd.K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KGK251166Mfinity Femoral SystemMedacta International S.A.K251052Trivicta® Hip StemOrtho Development Corp.K242315Resolve Modular Revision Hip StemUnited Orthopedic CorporationK243839Alteon® HA Femoral StemsExactech, Inc.

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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