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FDA 510(k)

3D KNEE

K-Number: K020114 · 2002-07-12

ApplicantEncore Orthopedics, Inc.
Decision Date2002-07-12
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

3D KNEE 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 2002-07-12 under 510(k) number K020114. 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 3D KNEE?

3D KNEE is a medical device that received FDA 510(k) clearance on 2002-07-12. The listed applicant is Encore Orthopedics, Inc.. The 510(k) number is K020114.

When did 3D KNEE receive FDA 510(k) clearance?

3D KNEE received FDA 510(k) clearance on 2002-07-12, under 510(k) number K020114.

Who is the listed applicant for 3D KNEE?

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 3D KNEE?

The FDA product code for 3D KNEE is JWH.

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 COMPONENTK020741UNICONDYLAR KNEEK020236MODIFICATION TO PASS SPINAL SYSTEMK020170KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UPK013490CEMENTED CALCAR HIP SYSTEMK013442PASS SPINAL 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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