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FDA 510(k)

PLUS BIPOLAR PROSTHESIS COCRMO

K-Number: K982447 · 1998-11-25

ApplicantPlus Orthopedics
Decision Date1998-11-25
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PLUS BIPOLAR PROSTHESIS COCRMO is the device name listed in this FDA 510(k) record. The listed applicant is Plus Orthopedics. It received FDA 510(k) clearance on 1998-11-25 under 510(k) number K982447. 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 PLUS BIPOLAR PROSTHESIS COCRMO?

PLUS BIPOLAR PROSTHESIS COCRMO is a medical device that received FDA 510(k) clearance on 1998-11-25. The listed applicant is Plus Orthopedics. The 510(k) number is K982447.

When did PLUS BIPOLAR PROSTHESIS COCRMO receive FDA 510(k) clearance?

PLUS BIPOLAR PROSTHESIS COCRMO received FDA 510(k) clearance on 1998-11-25, under 510(k) number K982447.

Who is the listed applicant for PLUS BIPOLAR PROSTHESIS COCRMO?

The FDA 510(k) record lists Plus Orthopedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLUS BIPOLAR PROSTHESIS COCRMO?

The FDA product code for PLUS BIPOLAR PROSTHESIS COCRMO is KWY.

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Other records listing Plus Orthopedics 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.

K032126PROMOS SHOULDERK033763MODIFICATION TO SLIM GLIDING NAIL SYSTEMK032709MODULAR PLUS HIP STEMK032548IP-XS COMPRESSION NAIL SYSTEMK032215VKS/TC-PLUS REVISION KNEEK032052UC-PLUS SOLUTION UNICONDYLAR KNEE

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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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