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FDA 510(k)

PROFORM POROUS ACETABULAR ASSEMBLY

K-Number: K950827 · 1995-04-18

ApplicantStelkast Company
Decision Date1995-04-18
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROFORM POROUS ACETABULAR ASSEMBLY is the device name listed in this FDA 510(k) record. The listed applicant is Stelkast Company. It received FDA 510(k) clearance on 1995-04-18 under 510(k) number K950827. 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 PROFORM POROUS ACETABULAR ASSEMBLY?

PROFORM POROUS ACETABULAR ASSEMBLY is a medical device that received FDA 510(k) clearance on 1995-04-18. The listed applicant is Stelkast Company. The 510(k) number is K950827.

When did PROFORM POROUS ACETABULAR ASSEMBLY receive FDA 510(k) clearance?

PROFORM POROUS ACETABULAR ASSEMBLY received FDA 510(k) clearance on 1995-04-18, under 510(k) number K950827.

Who is the listed applicant for PROFORM POROUS ACETABULAR ASSEMBLY?

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

What is the FDA product code for PROFORM POROUS ACETABULAR ASSEMBLY?

The FDA product code for PROFORM POROUS ACETABULAR ASSEMBLY is LPH.

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Other records listing Stelkast Company 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.

K122883EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEMK122773CROSS-OVER ACETABULAR SHELL & LINERK094035EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MMK081458PROVEN STEM EXTENDERK063211PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERTK051976PROVEN REVISION MODULAR TIBIAL TRAY

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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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