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FDA 510(k)

BAUMER PLATES

K-Number: K930966 · 1994-04-25

ApplicantBaumer Ortopedia , Ltd.
Decision Date1994-04-25
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BAUMER PLATES is the device name listed in this FDA 510(k) record. The listed applicant is Baumer Ortopedia , Ltd.. It received FDA 510(k) clearance on 1994-04-25 under 510(k) number K930966. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAUMER PLATES?

BAUMER PLATES is a medical device that received FDA 510(k) clearance on 1994-04-25. The listed applicant is Baumer Ortopedia , Ltd.. The 510(k) number is K930966.

When did BAUMER PLATES receive FDA 510(k) clearance?

BAUMER PLATES received FDA 510(k) clearance on 1994-04-25, under 510(k) number K930966.

Who is the listed applicant for BAUMER PLATES?

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

What is the FDA product code for BAUMER PLATES?

The FDA product code for BAUMER PLATES is HRS.

Related Clinical Trials

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.

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Other records listing Baumer Ortopedia , Ltd. 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.

K930972INTRAMEDULLARY SYSTEMSK930969BAUMER PINSK930967BAUMER STAPLESK930970BAUMER SCREWS

Related Devices (Code: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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