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FDA 510(k)

BAUMER SCREWS

K-Number: K930970 · 1994-01-07

ApplicantBaumer Ortopedia , Ltd.
Decision Date1994-01-07
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BAUMER SCREWS 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 1994-01-07 under 510(k) number K930970. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAUMER SCREWS?

BAUMER SCREWS is a medical device that received FDA 510(k) clearance on 1994-01-07. The listed applicant is Baumer Ortopedia , Ltd.. The 510(k) number is K930970.

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

BAUMER SCREWS received FDA 510(k) clearance on 1994-01-07, under 510(k) number K930970.

Who is the listed applicant for BAUMER SCREWS?

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 SCREWS?

The FDA product code for BAUMER SCREWS is HWC. This falls under the Cardiovascular category.

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 PINSK930967BAUMER STAPLES

Related Devices (Code: HWC)

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.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, Inc.

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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