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FDA 510(k)

BOFOR REVISION COUP

K-Number: K993874 · 2000-06-05

ApplicantPlus Orthopedics
Decision Date2000-06-05
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BOFOR REVISION COUP is the device name listed in this FDA 510(k) record. The listed applicant is Plus Orthopedics. It received FDA 510(k) clearance on 2000-06-05 under 510(k) number K993874. 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 BOFOR REVISION COUP?

BOFOR REVISION COUP is a medical device that received FDA 510(k) clearance on 2000-06-05. The listed applicant is Plus Orthopedics. The 510(k) number is K993874.

When did BOFOR REVISION COUP receive FDA 510(k) clearance?

BOFOR REVISION COUP received FDA 510(k) clearance on 2000-06-05, under 510(k) number K993874.

Who is the listed applicant for BOFOR REVISION COUP?

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 BOFOR REVISION COUP?

The FDA product code for BOFOR REVISION COUP 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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