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FDA 510(k)

BAUMER CEMENTED HIP PROSTHESIS

K-Number: K003975 · 2001-03-19

ApplicantBaumer, S.A
Decision Date2001-03-19
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BAUMER CEMENTED HIP PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Baumer, S.A. It received FDA 510(k) clearance on 2001-03-19 under 510(k) number K003975. 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 BAUMER CEMENTED HIP PROSTHESIS?

BAUMER CEMENTED HIP PROSTHESIS is a medical device that received FDA 510(k) clearance on 2001-03-19. The listed applicant is Baumer, S.A. The 510(k) number is K003975.

When did BAUMER CEMENTED HIP PROSTHESIS receive FDA 510(k) clearance?

BAUMER CEMENTED HIP PROSTHESIS received FDA 510(k) clearance on 2001-03-19, under 510(k) number K003975.

Who is the listed applicant for BAUMER CEMENTED HIP PROSTHESIS?

The FDA 510(k) record lists Baumer, S.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BAUMER CEMENTED HIP PROSTHESIS?

The FDA product code for BAUMER CEMENTED HIP PROSTHESIS is JDI.

Related Clinical Trials

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Other records listing Baumer, S.A 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.

K011504BAUMER LOCKING NAILK003976BAUMER MULLER HIP PROSTHESISK001571BAUMER FEMORAL HEAD

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

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