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FDA 510(k)

PSL TOTAL HIP REPLACEMENT SYSTEM

K-Number: K922500 · 1994-01-07

ApplicantBiopro, Inc.
Decision Date1994-01-07
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PSL TOTAL HIP REPLACEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biopro, Inc.. It received FDA 510(k) clearance on 1994-01-07 under 510(k) number K922500. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PSL TOTAL HIP REPLACEMENT SYSTEM?

PSL TOTAL HIP REPLACEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1994-01-07. The listed applicant is Biopro, Inc.. The 510(k) number is K922500.

When did PSL TOTAL HIP REPLACEMENT SYSTEM receive FDA 510(k) clearance?

PSL TOTAL HIP REPLACEMENT SYSTEM received FDA 510(k) clearance on 1994-01-07, under 510(k) number K922500.

Who is the listed applicant for PSL TOTAL HIP REPLACEMENT SYSTEM?

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

What is the FDA product code for PSL TOTAL HIP REPLACEMENT SYSTEM?

The FDA product code for PSL TOTAL HIP REPLACEMENT SYSTEM is LPH.

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Other records listing Biopro, Inc. as applicant

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K163627Shotel Ankle Arthrodesis Nail SystemK162674BioPro Foot Plating SystemsK132510BIOPRO - INFINITY PLATE ANCHOR SYSTEMK130298BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEMK121973BIOPRO HEMI-EDGE TOE SYSTEMK100761BIOPRO POLAR HEAD

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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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