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FDA 510(k)

REESE ARTHRODESIS SCREW

K-Number: K860323 · 1986-02-19

ApplicantOsteotomy Guide Co.
Decision Date1986-02-19
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REESE ARTHRODESIS SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Osteotomy Guide Co.. It received FDA 510(k) clearance on 1986-02-19 under 510(k) number K860323. 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 REESE ARTHRODESIS SCREW?

REESE ARTHRODESIS SCREW is a medical device that received FDA 510(k) clearance on 1986-02-19. The listed applicant is Osteotomy Guide Co.. The 510(k) number is K860323.

When did REESE ARTHRODESIS SCREW receive FDA 510(k) clearance?

REESE ARTHRODESIS SCREW received FDA 510(k) clearance on 1986-02-19, under 510(k) number K860323.

Who is the listed applicant for REESE ARTHRODESIS SCREW?

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

What is the FDA product code for REESE ARTHRODESIS SCREW?

The FDA product code for REESE ARTHRODESIS 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Osteotomy Guide Co. 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.

K861576SHORTENING OSTEOTOMY GUIDEK841470REESE OSTEOTOMY GUIDE SYS

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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