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FDA 510(k)

CORTICELLOUS BONE SCREW

K-Number: K953198 · 1995-11-24

ApplicantHayes Medical, Inc.
Decision Date1995-11-24
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

CORTICELLOUS BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Hayes Medical, Inc.. It received FDA 510(k) clearance on 1995-11-24 under 510(k) number K953198. 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 for Some Indications.

Frequently Asked Questions

What is the CORTICELLOUS BONE SCREW?

CORTICELLOUS BONE SCREW is a medical device that received FDA 510(k) clearance on 1995-11-24. The listed applicant is Hayes Medical, Inc.. The 510(k) number is K953198.

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

CORTICELLOUS BONE SCREW received FDA 510(k) clearance on 1995-11-24, under 510(k) number K953198.

Who is the listed applicant for CORTICELLOUS BONE SCREW?

The FDA 510(k) record lists Hayes Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORTICELLOUS BONE SCREW?

The FDA product code for CORTICELLOUS BONE SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Hayes Medical, Inc. 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.

K07006136MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERTK062383UNISYN HA PLASMA MODULAR HIPK060635CONSENSUS ACETABULAR SHELL SYSTEMK030151CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEMK030205CONSENSUS UNIPOLAR HEAD, COCRK021466CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE

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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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