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FDA 510(k)

ORTHOPEDIC PLATE SYSTEM

K-Number: K972219 · 1997-11-20

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

Device Summary

ORTHOPEDIC PLATE 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 K972219. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOPEDIC PLATE SYSTEM?

ORTHOPEDIC PLATE 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 K972219.

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

ORTHOPEDIC PLATE SYSTEM received FDA 510(k) clearance on 1997-11-20, under 510(k) number K972219.

Who is the listed applicant for ORTHOPEDIC PLATE 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 PLATE SYSTEM?

The FDA product code for ORTHOPEDIC PLATE SYSTEM is HRS.

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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 MRIK963794PUNCTURENEEDLEK971813EMBLAK972217ORTHOPEDIC SCREW SYSTEMK970819TARGOBEAM

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Related Devices (Code: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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