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FDA 510(k)

SWANSON TITANIUM CARPAL SCAPHOID IMPLANT

K-Number: K864490 · 1987-04-15

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

Device Summary

SWANSON TITANIUM CARPAL SCAPHOID 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 K864490. The device is classified under product code KWO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWANSON TITANIUM CARPAL SCAPHOID IMPLANT?

SWANSON TITANIUM CARPAL SCAPHOID 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 K864490.

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

SWANSON TITANIUM CARPAL SCAPHOID IMPLANT received FDA 510(k) clearance on 1987-04-15, under 510(k) number K864490.

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

The FDA product code for SWANSON TITANIUM CARPAL SCAPHOID IMPLANT is KWO.

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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

View all 74 devices →

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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