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FDA 510(k)

BAUMER STAPLES

K-Number: K930967 · 1994-03-07

ApplicantBaumer Ortopedia , Ltd.
Decision Date1994-03-07
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BAUMER STAPLES 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 1994-03-07 under 510(k) number K930967. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAUMER STAPLES?

BAUMER STAPLES is a medical device that received FDA 510(k) clearance on 1994-03-07. The listed applicant is Baumer Ortopedia , Ltd.. The 510(k) number is K930967.

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

BAUMER STAPLES received FDA 510(k) clearance on 1994-03-07, under 510(k) number K930967.

Who is the listed applicant for BAUMER STAPLES?

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 STAPLES?

The FDA product code for BAUMER STAPLES is JDR.

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.

K930966BAUMER PLATESK930972INTRAMEDULLARY SYSTEMSK930969BAUMER PINSK930970BAUMER SCREWS

Related Devices (Code: JDR)

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.

K262451Arthrex DynaNite StaplesArthrex, Inc.K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical Concepts

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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