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Newdeal Compression Plate

FDA 510(k)

Class II (US FDA 510(k))

510(k) K070447

by Newdeal Sas

Identifiers

510(k) Number
K070447 FDA 510(k)
FDA Product Code
HRS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3030 FDA 510(k)
Regulation Number
888.3030 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Newdeal Compression Plate is an orthopedic device designed for the fixation of bone fractures or bone reconstruction. It is indicated for use in procedures such as arthrodesis in hand or foot surgery, fracture management in the foot or hand, and mono or bi-cortical osteotomies.

This device is authorized under FDA 510(k) clearance K070447. It is manufactured by Newdeal Sas and is categorized under the orthopedic advisory committee.

Frequently asked questions

What is the primary clinical indication for the Newdeal Compression Plate?

This device is designed for orthopedic procedures involving bone fixation or reconstruction. Specifically, it is indicated for fracture management in the hand or foot, arthrodesis procedures, and both mono and bi-cortical osteotomies.

Under what regulatory authorization is this device supplied?

The Newdeal Compression Plate is supplied under FDA 510(k) clearance number K070447. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

Which medical specialty is this device intended for?

The device is categorized under the orthopedic advisory committee. It is specifically engineered for surgical applications within the hand and foot, supporting surgeons in complex bone reconstruction and stabilization tasks.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NEWDEAL COMPRESSION PLATES by NEWDEAL SAS | FDA 510(k) Summary, NEWDEAL COMPRESSION PLATE (K070447) — FDA 510(k) | Innolitics, NEWDEAL COMPRESSION PLATE (K091609) — FDA 510(k) | Innolitics, Newdeal Sas FDA 510 (k) Products (2007-2012)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Newdeal Sas

Sources (1)

  • FDA 510(k) K070447 24 fields · synced Sep 27, 2026