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FDA 510(k)

PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT

K-Number: K063211 · 2007-01-18

ApplicantStelkast Company
Decision Date2007-01-18
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT is the device name listed in this FDA 510(k) record. The listed applicant is Stelkast Company. It received FDA 510(k) clearance on 2007-01-18 under 510(k) number K063211. 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 KNEE SYSTEM HIGH FLEXION TIBIAL INSERT?

PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT is a medical device that received FDA 510(k) clearance on 2007-01-18. The listed applicant is Stelkast Company. The 510(k) number is K063211.

When did PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT receive FDA 510(k) clearance?

PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT received FDA 510(k) clearance on 2007-01-18, under 510(k) number K063211.

Who is the listed applicant for PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT?

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 KNEE SYSTEM HIGH FLEXION TIBIAL INSERT?

The FDA product code for PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT 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 EXTENDERK051976PROVEN 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.

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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