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FDA 510(k)

FOUNDATION KNEE SYSTEM TIBIAL COMPONENT

K-Number: K970031 · 1997-04-02

ApplicantEncore Orthopedics, Inc.
Decision Date1997-04-02
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FOUNDATION KNEE SYSTEM TIBIAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Encore Orthopedics, Inc.. It received FDA 510(k) clearance on 1997-04-02 under 510(k) number K970031. 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 FOUNDATION KNEE SYSTEM TIBIAL COMPONENT?

FOUNDATION KNEE SYSTEM TIBIAL COMPONENT is a medical device that received FDA 510(k) clearance on 1997-04-02. The listed applicant is Encore Orthopedics, Inc.. The 510(k) number is K970031.

When did FOUNDATION KNEE SYSTEM TIBIAL COMPONENT receive FDA 510(k) clearance?

FOUNDATION KNEE SYSTEM TIBIAL COMPONENT received FDA 510(k) clearance on 1997-04-02, under 510(k) number K970031.

Who is the listed applicant for FOUNDATION KNEE SYSTEM TIBIAL COMPONENT?

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

What is the FDA product code for FOUNDATION KNEE SYSTEM TIBIAL COMPONENT?

The FDA product code for FOUNDATION KNEE SYSTEM TIBIAL COMPONENT is JWH.

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Other records listing Encore Orthopedics, 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.

K0329053DKNEE POROUS COATED FEMORAL COMPONENTK0201143D KNEEK020741UNICONDYLAR KNEEK020236MODIFICATION TO PASS SPINAL SYSTEMK020170KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UPK013490CEMENTED CALCAR HIP SYSTEM

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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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