Cleared Traditional

K964328 - SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATE

K964328 is an FDA 510(k) clearance for SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE S..., manufactured by Synthes (Usa). The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K964328 · Synthes (Usa) · Dental device
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Optimized for regulatory review, auditing and printing
Dec 1996
Decision
44d
Days
Class 2
Risk

K964328 is an FDA 510(k) clearance for the SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATE. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on December 13, 1996 after a review of 44 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. 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K964328

510(k) Number K964328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1996
Decision Date December 13, 1996
Days to Decision 44 days
Submission Type Traditional
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
83d faster than avg
Panel avg: 127d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K964328.
LEE PLATE
K970911 · Howmedica Leibinger, Inc. · Apr 1997
INTRAORAL MANDIBULAR DISTRACTION DEVICE
K970256 · Medicon EG · Mar 1997
VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE
K964649 · Howmedica Leibinger, Inc. · Jan 1997
OSTEOMED TRAM
K963394 · Osteomed Corp. · Nov 1996
LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS
K963740 · Howmedica Leibinger, Inc. · Oct 1996
THE BIOPLATE FIXATION SYSTEM
K961976 · Biomedics · Aug 1996