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FDA 510(k)

ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT

K-Number: K932911 · 1994-06-30

ApplicantDow Corning Wright
Decision Date1994-06-30
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ORTHOLOC ADVANTIM L.S. 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 1994-06-30 under 510(k) number K932911. 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 ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT?

ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT is a medical device that received FDA 510(k) clearance on 1994-06-30. The listed applicant is Dow Corning Wright. The 510(k) number is K932911.

When did ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT receive FDA 510(k) clearance?

ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT received FDA 510(k) clearance on 1994-06-30, under 510(k) number K932911.

Who is the listed applicant for ORTHOLOC ADVANTIM L.S. 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 ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT?

The FDA product code for ORTHOLOC ADVANTIM L.S. 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 COMPONENTK934354LACEY ALL POLYETHYLENE 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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