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FDA 510(k)

NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA

K-Number: K002335 · 2000-10-25

ApplicantSulzer Orthopedics, Inc.
Decision Date2000-10-25
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA is the device name listed in this FDA 510(k) record. The listed applicant is Sulzer Orthopedics, Inc.. It received FDA 510(k) clearance on 2000-10-25 under 510(k) number K002335. 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 NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA?

NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA is a medical device that received FDA 510(k) clearance on 2000-10-25. The listed applicant is Sulzer Orthopedics, Inc.. The 510(k) number is K002335.

When did NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA receive FDA 510(k) clearance?

NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA received FDA 510(k) clearance on 2000-10-25, under 510(k) number K002335.

Who is the listed applicant for NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA?

The FDA 510(k) record lists Sulzer Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA?

The FDA product code for NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA is JWH.

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Other records listing Sulzer Orthopedics, Inc. 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.

K022985ASCENDENT ACETABULAR SYSTEMK021578NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATEK020713MS-30 LATERAL FEMORAL STEMK013935ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTSK013031MOST OPTIONS SYSTEMK012739CONVERGE ACETABULAR SYSTEM

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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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