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FDA 510(k)

PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA)

K-Number: K990261 · 1999-08-27

ApplicantPlus Orthopedics
Decision Date1999-08-27
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA) is the device name listed in this FDA 510(k) record. The listed applicant is Plus Orthopedics. It received FDA 510(k) clearance on 1999-08-27 under 510(k) number K990261. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA)?

PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA) is a medical device that received FDA 510(k) clearance on 1999-08-27. The listed applicant is Plus Orthopedics. The 510(k) number is K990261.

When did PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA) receive FDA 510(k) clearance?

PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA) received FDA 510(k) clearance on 1999-08-27, under 510(k) number K990261.

Who is the listed applicant for PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA)?

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 CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA)?

The FDA product code for PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA) is LZO.

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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: LZO)

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.

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic CorporationK261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast 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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