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FDA 510(k)

SULZER ORTHOPEDICS MS-30 FEMORAL STEM

K-Number: K001078 · 2000-06-23

ApplicantSulzer Orthopedics, Inc.
Decision Date2000-06-23
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SULZER ORTHOPEDICS MS-30 FEMORAL STEM 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 2000-06-23 under 510(k) number K001078. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SULZER ORTHOPEDICS MS-30 FEMORAL STEM?

SULZER ORTHOPEDICS MS-30 FEMORAL STEM is a medical device that received FDA 510(k) clearance on 2000-06-23. The listed applicant is Sulzer Orthopedics, Inc.. The 510(k) number is K001078.

When did SULZER ORTHOPEDICS MS-30 FEMORAL STEM receive FDA 510(k) clearance?

SULZER ORTHOPEDICS MS-30 FEMORAL STEM received FDA 510(k) clearance on 2000-06-23, under 510(k) number K001078.

Who is the listed applicant for SULZER ORTHOPEDICS MS-30 FEMORAL STEM?

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 SULZER ORTHOPEDICS MS-30 FEMORAL STEM?

The FDA product code for SULZER ORTHOPEDICS MS-30 FEMORAL STEM is JDI.

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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: JDI)

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.

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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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