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FDA 510(k)

NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS

K-Number: K983153 · 1998-12-04

ApplicantSulzer Orthopedics, Inc.
Decision Date1998-12-04
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS 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 1998-12-04 under 510(k) number K983153. 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 POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS?

NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS is a medical device that received FDA 510(k) clearance on 1998-12-04. The listed applicant is Sulzer Orthopedics, Inc.. The 510(k) number is K983153.

When did NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS receive FDA 510(k) clearance?

NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS received FDA 510(k) clearance on 1998-12-04, under 510(k) number K983153.

Who is the listed applicant for NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS?

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 POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS?

The FDA product code for NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS 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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