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FDA 510(k)

SYMMETRIC TOTAL KNEE SYSTEM

K-Number: K080199 · 2008-07-03

ApplicantSignal Medical Corporation
Decision Date2008-07-03
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYMMETRIC TOTAL KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Signal Medical Corporation. It received FDA 510(k) clearance on 2008-07-03 under 510(k) number K080199. 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 SYMMETRIC TOTAL KNEE SYSTEM?

SYMMETRIC TOTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2008-07-03. The listed applicant is Signal Medical Corporation. The 510(k) number is K080199.

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

SYMMETRIC TOTAL KNEE SYSTEM received FDA 510(k) clearance on 2008-07-03, under 510(k) number K080199.

Who is the listed applicant for SYMMETRIC TOTAL KNEE SYSTEM?

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

What is the FDA product code for SYMMETRIC TOTAL KNEE SYSTEM?

The FDA product code for SYMMETRIC TOTAL KNEE SYSTEM is JWH.

Related Clinical Trials

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.

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Other records listing Signal Medical Corporation 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.

K203779Symmetric Total Knee System

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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