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FDA 510(k)

IFS PROFILE PLATES, SCREWS, AND WASHERS

K-Number: K110086 · 2011-09-09

ApplicantInternal Fixation Systems, Inc.
Decision Date2011-09-09
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IFS PROFILE PLATES, SCREWS, AND WASHERS is the device name listed in this FDA 510(k) record. The listed applicant is Internal Fixation Systems, Inc.. It received FDA 510(k) clearance on 2011-09-09 under 510(k) number K110086. 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 IFS PROFILE PLATES, SCREWS, AND WASHERS?

IFS PROFILE PLATES, SCREWS, AND WASHERS is a medical device that received FDA 510(k) clearance on 2011-09-09. The listed applicant is Internal Fixation Systems, Inc.. The 510(k) number is K110086.

When did IFS PROFILE PLATES, SCREWS, AND WASHERS receive FDA 510(k) clearance?

IFS PROFILE PLATES, SCREWS, AND WASHERS received FDA 510(k) clearance on 2011-09-09, under 510(k) number K110086.

Who is the listed applicant for IFS PROFILE PLATES, SCREWS, AND WASHERS?

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

What is the FDA product code for IFS PROFILE PLATES, SCREWS, AND WASHERS?

The FDA product code for IFS PROFILE PLATES, SCREWS, AND WASHERS is HRS.

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 Internal Fixation Systems, 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.

K113399IFS SUBTALAR IMPLANTK071035IFS BONE FIXATION DEVICESK061620IFS CANNULATED BONE SCREW

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

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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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