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FDA 510(k)

OPTI-FIX TOTAL HIP SYSTEM

K-Number: K860635 · 1986-03-14

ApplicantRichards Medical Co., Inc.
Decision Date1986-03-14
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

OPTI-FIX TOTAL HIP SYSTEM 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 1986-03-14 under 510(k) number K860635. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the OPTI-FIX TOTAL HIP SYSTEM?

OPTI-FIX TOTAL HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1986-03-14. The listed applicant is Richards Medical Co., Inc.. The 510(k) number is K860635.

When did OPTI-FIX TOTAL HIP SYSTEM receive FDA 510(k) clearance?

OPTI-FIX TOTAL HIP SYSTEM received FDA 510(k) clearance on 1986-03-14, under 510(k) number K860635.

Who is the listed applicant for OPTI-FIX TOTAL HIP SYSTEM?

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 OPTI-FIX TOTAL HIP SYSTEM?

The FDA product code for OPTI-FIX TOTAL HIP SYSTEM is LPH.

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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: LPH)

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.

K261453G7® Acetabular SystemZimmer BiometK253630Mpact 3D Metal FoamMedacta International S.A.K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLCK251270Taperloc® Complete Hip StemBiomet, Inc.

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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