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FDA 510(k)

ALTA CFX IM ROD SYSTEM

K-Number: K960524 · 1996-03-22

ApplicantHowmedica Corp.
Decision Date1996-03-22
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALTA CFX IM ROD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1996-03-22 under 510(k) number K960524. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALTA CFX IM ROD SYSTEM?

ALTA CFX IM ROD SYSTEM is a medical device that received FDA 510(k) clearance on 1996-03-22. The listed applicant is Howmedica Corp.. The 510(k) number is K960524.

When did ALTA CFX IM ROD SYSTEM receive FDA 510(k) clearance?

ALTA CFX IM ROD SYSTEM received FDA 510(k) clearance on 1996-03-22, under 510(k) number K960524.

Who is the listed applicant for ALTA CFX IM ROD SYSTEM?

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

What is the FDA product code for ALTA CFX IM ROD SYSTEM?

The FDA product code for ALTA CFX IM ROD SYSTEM is HSB.

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Other records listing Howmedica Corp. as applicant

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K983528MICRO DYNAMIC MESHK983404TYPE 3 FEMORAL COMPONENTSK980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONK980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATIONK980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONK980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

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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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