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FDA 510(k)

PROVEN STEM EXTENDER

K-Number: K081458 · 2008-06-06

ApplicantStelkast Company
Decision Date2008-06-06
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROVEN STEM EXTENDER is the device name listed in this FDA 510(k) record. The listed applicant is Stelkast Company. It received FDA 510(k) clearance on 2008-06-06 under 510(k) number K081458. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROVEN STEM EXTENDER?

PROVEN STEM EXTENDER is a medical device that received FDA 510(k) clearance on 2008-06-06. The listed applicant is Stelkast Company. The 510(k) number is K081458.

When did PROVEN STEM EXTENDER receive FDA 510(k) clearance?

PROVEN STEM EXTENDER received FDA 510(k) clearance on 2008-06-06, under 510(k) number K081458.

Who is the listed applicant for PROVEN STEM EXTENDER?

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 PROVEN STEM EXTENDER?

The FDA product code for PROVEN STEM EXTENDER is JWH.

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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 28MMK063211PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERTK051976PROVEN REVISION MODULAR TIBIAL TRAYK033944STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD

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Related Devices (Code: JWH)

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.

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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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