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FDA 510(k)

PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING

K-Number: K910755 · 1991-03-26

ApplicantIntermedics Orthopedics
Decision Date1991-03-26
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1991-03-26 under 510(k) number K910755. 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 PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING?

PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING is a medical device that received FDA 510(k) clearance on 1991-03-26. The listed applicant is Intermedics Orthopedics. The 510(k) number is K910755.

When did PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING receive FDA 510(k) clearance?

PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING received FDA 510(k) clearance on 1991-03-26, under 510(k) number K910755.

Who is the listed applicant for PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING?

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

What is the FDA product code for PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING?

The FDA product code for PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING is MEH.

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Other records listing Intermedics Orthopedics as applicant

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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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