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FDA 510(k)

NEWDEAL TIBIAXYS SYSTEM

K-Number: K073375 · 2008-02-21

ApplicantNewdeal Sas
Decision Date2008-02-21
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEWDEAL TIBIAXYS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Newdeal Sas. It received FDA 510(k) clearance on 2008-02-21 under 510(k) number K073375. 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 NEWDEAL TIBIAXYS SYSTEM?

NEWDEAL TIBIAXYS SYSTEM is a medical device that received FDA 510(k) clearance on 2008-02-21. The listed applicant is Newdeal Sas. The 510(k) number is K073375.

When did NEWDEAL TIBIAXYS SYSTEM receive FDA 510(k) clearance?

NEWDEAL TIBIAXYS SYSTEM received FDA 510(k) clearance on 2008-02-21, under 510(k) number K073375.

Who is the listed applicant for NEWDEAL TIBIAXYS SYSTEM?

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

What is the FDA product code for NEWDEAL TIBIAXYS SYSTEM?

The FDA product code for NEWDEAL TIBIAXYS SYSTEM is HRS.

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Other records listing Newdeal Sas 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.

K103623NEWDEAL INTERPHALANGEAL IMPLANTK093914NEWDEAL COMPRESSION PLATESK093781MODIFIED: NEWDEAL HALLU PLATESK091788PANTA NAIL (DIA. 10MM), PANTA NAIL XLK083154NEWDEAL HALLU LOCK PLATE SYSTEMK091609NEWDEAL COMPRESSION PLATE

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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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