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FDA 510(k)

EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM

K-Number: K094035 · 2011-03-24

ApplicantStelkast Company
Decision Date2011-03-24
Product CodeOQG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM is the device name listed in this FDA 510(k) record. The listed applicant is Stelkast Company. It received FDA 510(k) clearance on 2011-03-24 under 510(k) number K094035. The device is classified under product code OQG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM?

EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM is a medical device that received FDA 510(k) clearance on 2011-03-24. The listed applicant is Stelkast Company. The 510(k) number is K094035.

When did EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM receive FDA 510(k) clearance?

EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM received FDA 510(k) clearance on 2011-03-24, under 510(k) number K094035.

Who is the listed applicant for EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM?

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 EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM?

The FDA product code for EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM is OQG.

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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 & LINERK081458PROVEN STEM EXTENDERK063211PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERTK051976PROVEN REVISION MODULAR TIBIAL TRAYK033944STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD

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Related Devices (Code: OQG)

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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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