Cleared Special

K033160 - SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES

K033160 is an FDA 510(k) clearance for SYNTHES STERILE LOW PROFILE NEURO CONTO..., manufactured by Synthes (Usa). The device is a Class 2 Dental device with product code JEY cleared through the Special 510(k) pathway after a 9-day FDA review.

K033160 · Synthes (Usa) · Dental device
Download Printable Device Report (PDF)
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Oct 2003
Decision
9d
Days
Class 2
Risk

K033160 is an FDA 510(k) clearance for the SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on October 9, 2003 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Synthes (Usa) devices

FDA 510(k) Submission Details - K033160

510(k) Number K033160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2003
Decision Date October 09, 2003
Days to Decision 9 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 127d · This submission: 9d
Pathway characteristics
Modification to existing cleared device.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 Dental devices follow this clearance model.

Regulatory Peers - JEY Plate, Bone

All 249
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K033160.
SYNTHES (USA) CRANIOFACIAL PLATES
K040272 · Synthes (Usa) · Feb 2004
INION CPS BABY 1.5 BIOABSORBABLE SYSTEM
K033194 · Inion , Ltd. · Oct 2003
1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES
K033121 · Synthes (Usa) · Oct 2003
UNIVERSAL NEURO SYSTEM
K031659 · Stryker Instruments · Sep 2003
SYNTHES (USA) NEW/STERIAL ORBITAL PLATES
K031761 · Synthes (Usa) · Sep 2003
OSTEOMED 2.0 LOCKING PLATES AND SCREWS
K030448 · Osteomed LP · May 2003