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FDA 510(k)

NEWDEAL COMPRESSION PLATES

K-Number: K093914 · 2011-04-14

ApplicantNewdeal Sas
Decision Date2011-04-14
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEWDEAL COMPRESSION PLATES is the device name listed in this FDA 510(k) record. The listed applicant is Newdeal Sas. It received FDA 510(k) clearance on 2011-04-14 under 510(k) number K093914. 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 COMPRESSION PLATES?

NEWDEAL COMPRESSION PLATES is a medical device that received FDA 510(k) clearance on 2011-04-14. The listed applicant is Newdeal Sas. The 510(k) number is K093914.

When did NEWDEAL COMPRESSION PLATES receive FDA 510(k) clearance?

NEWDEAL COMPRESSION PLATES received FDA 510(k) clearance on 2011-04-14, under 510(k) number K093914.

Who is the listed applicant for NEWDEAL COMPRESSION PLATES?

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 COMPRESSION PLATES?

The FDA product code for NEWDEAL COMPRESSION PLATES 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 IMPLANTK093781MODIFIED: NEWDEAL HALLU PLATESK091788PANTA NAIL (DIA. 10MM), PANTA NAIL XLK083154NEWDEAL HALLU LOCK PLATE SYSTEMK091609NEWDEAL COMPRESSION PLATEK073375NEWDEAL TIBIAXYS SYSTEM

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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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