Cleared Traditional

K083154 - NEWDEAL HALLU LOCK PLATE SYSTEM

K083154 is an FDA 510(k) clearance for NEWDEAL HALLU LOCK PLATE SYSTEM, 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 259-day FDA review.

K083154 · Newdeal Sas · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
259d
Days
Class 2
Risk

K083154 is an FDA 510(k) clearance for the NEWDEAL HALLU LOCK PLATE SYSTEM. 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 July 10, 2009 after a review of 259 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Newdeal Sas devices

FDA 510(k) Submission Details - K083154

510(k) Number K083154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2008
Decision Date July 10, 2009
Days to Decision 259 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
137d slower than avg
Panel avg: 122d · This submission: 259d
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 K083154.
LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE,
K091294 · DePuy Orthopaedics, Inc. · Jul 2009
TRIMED STERILE PRODUCT
K091156 · TriMed, Inc. · Jul 2009
APTUS FOOT SYSTEM
K091479 · Medartis AG · Jul 2009
OSTEOMED HAND PLATE AND SCREW FIXATION SYSTEM
K090522 · Osteomed LP · Jul 2009
CALCANEAL FRACTURE PLATE SYSTEM
K090582 · Tornier, Inc. · Jul 2009
APTUS 2.0/2.3 FOUR CORNER FUSION PLATE
K090983 · Medartis AG · Jul 2009