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FDA 510(k)

CONSENSUS KNEE SYSTEM

K-Number: K001456 · 2000-08-07

ApplicantHayes Medical, Inc.
Decision Date2000-08-07
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONSENSUS KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hayes Medical, Inc.. It received FDA 510(k) clearance on 2000-08-07 under 510(k) number K001456. 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 CONSENSUS KNEE SYSTEM?

CONSENSUS KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2000-08-07. The listed applicant is Hayes Medical, Inc.. The 510(k) number is K001456.

When did CONSENSUS KNEE SYSTEM receive FDA 510(k) clearance?

CONSENSUS KNEE SYSTEM received FDA 510(k) clearance on 2000-08-07, under 510(k) number K001456.

Who is the listed applicant for CONSENSUS KNEE SYSTEM?

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

What is the FDA product code for CONSENSUS KNEE SYSTEM?

The FDA product code for CONSENSUS KNEE SYSTEM is JWH.

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Other records listing Hayes Medical, 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.

K07006136MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERTK062383UNISYN HA PLASMA MODULAR HIPK060635CONSENSUS ACETABULAR SHELL SYSTEMK030151CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEMK030205CONSENSUS UNIPOLAR HEAD, COCRK021466CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE

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Related Devices (Code: JWH)

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.

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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