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FDA 510(k)

BAUMER FEMORAL HEAD

K-Number: K001571 · 2000-08-04

ApplicantBaumer, S.A
Decision Date2000-08-04
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BAUMER FEMORAL HEAD 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 2000-08-04 under 510(k) number K001571. 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 FEMORAL HEAD?

BAUMER FEMORAL HEAD is a medical device that received FDA 510(k) clearance on 2000-08-04. The listed applicant is Baumer, S.A. The 510(k) number is K001571.

When did BAUMER FEMORAL HEAD receive FDA 510(k) clearance?

BAUMER FEMORAL HEAD received FDA 510(k) clearance on 2000-08-04, under 510(k) number K001571.

Who is the listed applicant for BAUMER FEMORAL HEAD?

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 FEMORAL HEAD?

The FDA product code for BAUMER FEMORAL HEAD is JDI.

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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 PROSTHESISK003975BAUMER CEMENTED HIP PROSTHESIS

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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