Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ORTHOPEDIC SCREW SYSTEM

K-Number: K972217 · 1997-11-20

ApplicantFerguson Medical
Decision Date1997-11-20
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOPEDIC SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ferguson Medical. It received FDA 510(k) clearance on 1997-11-20 under 510(k) number K972217. 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 ORTHOPEDIC SCREW SYSTEM?

ORTHOPEDIC SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 1997-11-20. The listed applicant is Ferguson Medical. The 510(k) number is K972217.

When did ORTHOPEDIC SCREW SYSTEM receive FDA 510(k) clearance?

ORTHOPEDIC SCREW SYSTEM received FDA 510(k) clearance on 1997-11-20, under 510(k) number K972217.

Who is the listed applicant for ORTHOPEDIC SCREW SYSTEM?

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

What is the FDA product code for ORTHOPEDIC SCREW SYSTEM?

The FDA product code for ORTHOPEDIC SCREW SYSTEM 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 Ferguson Medical 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.

K033153DICOM THEATERK962615TUMORLOCALIZER MRIK963794PUNCTURENEEDLEK971813EMBLAK972219ORTHOPEDIC PLATE SYSTEMK970819TARGOBEAM

View all 57 devices →

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.

↑