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FDA 510(k)

MAGNA-ROM 21 KNEE SYSTEEM

K-Number: K991143 · 1999-06-11

ApplicantSulzer Orthopedics, Inc.
Decision Date1999-06-11
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAGNA-ROM 21 KNEE SYSTEEM 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 1999-06-11 under 510(k) number K991143. 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 MAGNA-ROM 21 KNEE SYSTEEM?

MAGNA-ROM 21 KNEE SYSTEEM is a medical device that received FDA 510(k) clearance on 1999-06-11. The listed applicant is Sulzer Orthopedics, Inc.. The 510(k) number is K991143.

When did MAGNA-ROM 21 KNEE SYSTEEM receive FDA 510(k) clearance?

MAGNA-ROM 21 KNEE SYSTEEM received FDA 510(k) clearance on 1999-06-11, under 510(k) number K991143.

Who is the listed applicant for MAGNA-ROM 21 KNEE SYSTEEM?

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 MAGNA-ROM 21 KNEE SYSTEEM?

The FDA product code for MAGNA-ROM 21 KNEE SYSTEEM 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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