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FDA 510(k)

LACEY PRESS-FIT CONDYLAR TOTAL KNEE

K-Number: K864518 · 1987-03-04

ApplicantDow Corning Wright
Decision Date1987-03-04
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

LACEY PRESS-FIT CONDYLAR TOTAL KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Dow Corning Wright. It received FDA 510(k) clearance on 1987-03-04 under 510(k) number K864518. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the LACEY PRESS-FIT CONDYLAR TOTAL KNEE?

LACEY PRESS-FIT CONDYLAR TOTAL KNEE is a medical device that received FDA 510(k) clearance on 1987-03-04. The listed applicant is Dow Corning Wright. The 510(k) number is K864518.

When did LACEY PRESS-FIT CONDYLAR TOTAL KNEE receive FDA 510(k) clearance?

LACEY PRESS-FIT CONDYLAR TOTAL KNEE received FDA 510(k) clearance on 1987-03-04, under 510(k) number K864518.

Who is the listed applicant for LACEY PRESS-FIT CONDYLAR TOTAL KNEE?

The FDA 510(k) record lists Dow Corning Wright as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LACEY PRESS-FIT CONDYLAR TOTAL KNEE?

The FDA product code for LACEY PRESS-FIT CONDYLAR TOTAL KNEE is JWH.

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Other records listing Dow Corning Wright 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.

K932210ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENTK932911ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENTK934354LACEY ALL POLYETHYLENE TIBIAL COMPONENTK932222SLT FEMORAL HEADK932858ORTHOLOC ADVANTIM TIBIAL BASE COMPONENTK930228ORTHOLOC ADVANTIM TIBIAL STEM 5 DEGREE

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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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