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FDA 510(k)

LACEY ALL POLYETHYLENE TIBIAL COMPONENT

K-Number: K934354 · 1994-06-03

ApplicantDow Corning Wright
Decision Date1994-06-03
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LACEY ALL POLYETHYLENE TIBIAL COMPONENT 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 1994-06-03 under 510(k) number K934354. 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 LACEY ALL POLYETHYLENE TIBIAL COMPONENT?

LACEY ALL POLYETHYLENE TIBIAL COMPONENT is a medical device that received FDA 510(k) clearance on 1994-06-03. The listed applicant is Dow Corning Wright. The 510(k) number is K934354.

When did LACEY ALL POLYETHYLENE TIBIAL COMPONENT receive FDA 510(k) clearance?

LACEY ALL POLYETHYLENE TIBIAL COMPONENT received FDA 510(k) clearance on 1994-06-03, under 510(k) number K934354.

Who is the listed applicant for LACEY ALL POLYETHYLENE TIBIAL COMPONENT?

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 ALL POLYETHYLENE TIBIAL COMPONENT?

The FDA product code for LACEY ALL POLYETHYLENE TIBIAL COMPONENT 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 COMPONENTK932222SLT FEMORAL HEADK932858ORTHOLOC ADVANTIM TIBIAL BASE COMPONENTK930228ORTHOLOC ADVANTIM TIBIAL STEM 5 DEGREEK925900LACEY REVISION FEMORAL COMPONENT

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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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