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FDA 510(k)

STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM

K-Number: K980276 · 1998-04-24

ApplicantStelkast Company
Decision Date1998-04-24
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stelkast Company. It received FDA 510(k) clearance on 1998-04-24 under 510(k) number K980276. 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 STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM?

STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 1998-04-24. The listed applicant is Stelkast Company. The 510(k) number is K980276.

When did STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM receive FDA 510(k) clearance?

STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM received FDA 510(k) clearance on 1998-04-24, under 510(k) number K980276.

Who is the listed applicant for STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM?

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 PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM?

The FDA product code for STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM 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 28MMK081458PROVEN STEM EXTENDERK063211PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERTK051976PROVEN REVISION MODULAR TIBIAL TRAY

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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.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

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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