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FDA 510(k)

SWANSON TITANIUM CARPAL LUNATE IMPLANT

K-Number: K864491 · 1987-04-15

ApplicantDow Corning Wright
Decision Date1987-04-15
Product CodeKWN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SWANSON TITANIUM CARPAL LUNATE IMPLANT 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 1987-04-15 under 510(k) number K864491. The device is classified under product code KWN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWANSON TITANIUM CARPAL LUNATE IMPLANT?

SWANSON TITANIUM CARPAL LUNATE IMPLANT is a medical device that received FDA 510(k) clearance on 1987-04-15. The listed applicant is Dow Corning Wright. The 510(k) number is K864491.

When did SWANSON TITANIUM CARPAL LUNATE IMPLANT receive FDA 510(k) clearance?

SWANSON TITANIUM CARPAL LUNATE IMPLANT received FDA 510(k) clearance on 1987-04-15, under 510(k) number K864491.

Who is the listed applicant for SWANSON TITANIUM CARPAL LUNATE IMPLANT?

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 SWANSON TITANIUM CARPAL LUNATE IMPLANT?

The FDA product code for SWANSON TITANIUM CARPAL LUNATE IMPLANT is KWN.

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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: KWN)

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.

K080997ASCENSION PYROCARBON LUNATEAscension Orthopedics, Inc.K050028MAESTRO CARPAL HEMIARTHROPLASTYBiomet Manufacturing, Inc.K790793AMC R METACARPAL COMPONENTHowmedica Corp.

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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