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FDA 510(k)

CLOUTIER II FIBER METAL TOTAL KNEE

K-Number: K833363 · 1984-02-13

ApplicantZimmer, Inc.
Decision Date1984-02-13
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CLOUTIER II FIBER METAL TOTAL KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1984-02-13 under 510(k) number K833363. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLOUTIER II FIBER METAL TOTAL KNEE?

CLOUTIER II FIBER METAL TOTAL KNEE is a medical device that received FDA 510(k) clearance on 1984-02-13. The listed applicant is Zimmer, Inc.. The 510(k) number is K833363.

When did CLOUTIER II FIBER METAL TOTAL KNEE receive FDA 510(k) clearance?

CLOUTIER II FIBER METAL TOTAL KNEE received FDA 510(k) clearance on 1984-02-13, under 510(k) number K833363.

Who is the listed applicant for CLOUTIER II FIBER METAL TOTAL KNEE?

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

What is the FDA product code for CLOUTIER II FIBER METAL TOTAL KNEE?

The FDA product code for CLOUTIER II FIBER METAL TOTAL KNEE is JWH.

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Related Devices (Code: JWH)

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K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

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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