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FDA 510(k)

EPOCA CODR STEM AND HEAD

K-Number: K014049 · 2002-01-09

ApplicantStelkast Company
Decision Date2002-01-09
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EPOCA CODR STEM AND HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Stelkast Company. It received FDA 510(k) clearance on 2002-01-09 under 510(k) number K014049. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPOCA CODR STEM AND HEAD?

EPOCA CODR STEM AND HEAD is a medical device that received FDA 510(k) clearance on 2002-01-09. The listed applicant is Stelkast Company. The 510(k) number is K014049.

When did EPOCA CODR STEM AND HEAD receive FDA 510(k) clearance?

EPOCA CODR STEM AND HEAD received FDA 510(k) clearance on 2002-01-09, under 510(k) number K014049.

Who is the listed applicant for EPOCA CODR STEM AND HEAD?

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 EPOCA CODR STEM AND HEAD?

The FDA product code for EPOCA CODR STEM AND HEAD is KWT.

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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: KWT)

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.

K262173N22 Offset Humeral HeadShoulder Innovations, Inc.K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbHK241817InSet Total Shoulder SystemShoulder Innovations, Inc.K231657AGILON® XO Shoulder Replacement SystemImplantcast 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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