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FDA 510(k)

TI-FIT ACETABULAR COMPONENT

K-Number: K860275 · 1986-04-03

ApplicantRichards Medical Co., Inc.
Decision Date1986-04-03
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TI-FIT ACETABULAR COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Richards Medical Co., Inc.. It received FDA 510(k) clearance on 1986-04-03 under 510(k) number K860275. 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 TI-FIT ACETABULAR COMPONENT?

TI-FIT ACETABULAR COMPONENT is a medical device that received FDA 510(k) clearance on 1986-04-03. The listed applicant is Richards Medical Co., Inc.. The 510(k) number is K860275.

When did TI-FIT ACETABULAR COMPONENT receive FDA 510(k) clearance?

TI-FIT ACETABULAR COMPONENT received FDA 510(k) clearance on 1986-04-03, under 510(k) number K860275.

Who is the listed applicant for TI-FIT ACETABULAR COMPONENT?

The FDA 510(k) record lists Richards Medical Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TI-FIT ACETABULAR COMPONENT?

The FDA product code for TI-FIT ACETABULAR COMPONENT is LZO.

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Other records listing Richards Medical Co., Inc. 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.

K896106ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTSK900628MODULAR HIP SYSTEMK896580UNI-POLAR HEADK895241INTRAMEDULLARY HIP SCREWK884824TRICON-M TOTAL KNEE SYSTEMK896204ZIRCONIA CERAMIC HEAD ADD'L SIZES

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Related Devices (Code: LZO)

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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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