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FDA 510(k)

BONE FIXACTION SCREW

K-Number: K810497 · 1981-03-11

ApplicantSerrano Intl.
Decision Date1981-03-11
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BONE FIXACTION SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Serrano Intl.. It received FDA 510(k) clearance on 1981-03-11 under 510(k) number K810497. 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 BONE FIXACTION SCREW?

BONE FIXACTION SCREW is a medical device that received FDA 510(k) clearance on 1981-03-11. The listed applicant is Serrano Intl.. The 510(k) number is K810497.

When did BONE FIXACTION SCREW receive FDA 510(k) clearance?

BONE FIXACTION SCREW received FDA 510(k) clearance on 1981-03-11, under 510(k) number K810497.

Who is the listed applicant for BONE FIXACTION SCREW?

The FDA 510(k) record lists Serrano Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BONE FIXACTION SCREW?

The FDA product code for BONE FIXACTION SCREW 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 Serrano Intl. 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.

K851409UNILOC TOTAL HIP PROSTHESISK820899MECRON VOORHOEVE TITANIUM SHEATHK820619MECRON(R) ACETABULAR NETS TMK820852MECRON CONCAVEX FLEXIBLE INTRAMEDULLARYK810205MECRON CANCELLOUS CANNULATED BONE SCREWS

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

View on FDA Database →

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

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