Cleared Traditional

K070447 - NEWDEAL COMPRESSION PLATE

K070447 is an FDA 510(k) clearance for NEWDEAL COMPRESSION PLATE, manufactured by Newdeal Sas. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K070447 · Newdeal Sas · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
42d
Days
Class 2
Risk

K070447 is an FDA 510(k) clearance for the NEWDEAL COMPRESSION PLATE. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Newdeal Sas (Planisboro, US). The FDA issued a Cleared decision on March 29, 2007 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Newdeal Sas devices

FDA 510(k) Submission Details - K070447

510(k) Number K070447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2007
Decision Date March 29, 2007
Days to Decision 42 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 122d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRS Plate, Fixation, Bone

All 1054
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K070447.
SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM
K071184 · Synthes (Usa) · Jun 2007
SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATES
K070946 · Synthes (Usa) · Jun 2007
SBI DISTAL RADIUS VOLAR PLATING SYSTEM
K070793 · Small Bone Innovations, Inc. · May 2007
SYNTHES 4.5 MM LCP POSTEROLATERAL PROXIMAL FEMUR PLATES
K070208 · Synthes (Usa) · Mar 2007
KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE
K070169 · KLS-Martin L.P. · Mar 2007
STRYKER FOOT PLATING SYSTEM
K063875 · Howmedica Osteonics Corp. · Mar 2007