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FDA 510(k)

STELKAST ALL POLYETHYLENE ACETABULAR CUP

K-Number: K953169 · 1995-08-08

ApplicantStelkast Company
Decision Date1995-08-08
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STELKAST ALL POLYETHYLENE ACETABULAR CUP is the device name listed in this FDA 510(k) record. The listed applicant is Stelkast Company. It received FDA 510(k) clearance on 1995-08-08 under 510(k) number K953169. 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 STELKAST ALL POLYETHYLENE ACETABULAR CUP?

STELKAST ALL POLYETHYLENE ACETABULAR CUP is a medical device that received FDA 510(k) clearance on 1995-08-08. The listed applicant is Stelkast Company. The 510(k) number is K953169.

When did STELKAST ALL POLYETHYLENE ACETABULAR CUP receive FDA 510(k) clearance?

STELKAST ALL POLYETHYLENE ACETABULAR CUP received FDA 510(k) clearance on 1995-08-08, under 510(k) number K953169.

Who is the listed applicant for STELKAST ALL POLYETHYLENE ACETABULAR CUP?

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 STELKAST ALL POLYETHYLENE ACETABULAR CUP?

The FDA product code for STELKAST ALL POLYETHYLENE ACETABULAR CUP is LZO.

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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: 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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