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FDA 510(k)

SLR BIPOLAR HIP ENDOPROSTHESIS

K-Number: K861566 · 1986-05-12

ApplicantDow Corning Wright
Decision Date1986-05-12
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SLR BIPOLAR HIP ENDOPROSTHESIS 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 1986-05-12 under 510(k) number K861566. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLR BIPOLAR HIP ENDOPROSTHESIS?

SLR BIPOLAR HIP ENDOPROSTHESIS is a medical device that received FDA 510(k) clearance on 1986-05-12. The listed applicant is Dow Corning Wright. The 510(k) number is K861566.

When did SLR BIPOLAR HIP ENDOPROSTHESIS receive FDA 510(k) clearance?

SLR BIPOLAR HIP ENDOPROSTHESIS received FDA 510(k) clearance on 1986-05-12, under 510(k) number K861566.

Who is the listed applicant for SLR BIPOLAR HIP ENDOPROSTHESIS?

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 SLR BIPOLAR HIP ENDOPROSTHESIS?

The FDA product code for SLR BIPOLAR HIP ENDOPROSTHESIS is KWY.

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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.

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Related Devices (Code: KWY)

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.

K253357b-ONE® Bipolar HeadB-One Ortho, Corp.K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc.K231526CORAIL Cemented Femoral StemDepuy Ireland UCK223441SpaceFlex Acetabular CupG21, S.R.L.K221794Vario-Cup SystemWaldemar Link GmbH & Co. KGK220492COPAL exchange G hip spacerHeraeus Medical GmbH

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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