Cleared Traditional

SYNTHES CERVICAL VERTABRAE PLATES (K792352) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K792352 · DePuy Synthes · Orthopedic device
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Dec 1979
Decision
17d
Days
Class 2
Risk

K792352 is an FDA 510(k) clearance for the SYNTHES CERVICAL VERTABRAE PLATES. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by DePuy Synthes (Raynham, US). The FDA issued a Cleared decision on December 6, 1979 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 DePuy Synthes devices

Submission Details

510(k) Number K792352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1979
Decision Date December 06, 1979
Days to Decision 17 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 122d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 244
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K792352.
AESCULAP TITANIUM BONE PLATES
K913730 · Aesculap, Inc. · Mar 1992
BRADFORD SPINAL FRACTURE FIXATION SYS
K831982 · Depuy, Inc. · Sep 1983
ANTERIOR KYPHOSIS DISTRACTION DEVICE
K802222 · Zimmer, Inc. · Oct 1980
D.T.T. LOCK SCREW INSERTER
K790941 · Depuy, Inc. · May 1979
DTT SYSTEM
K790404 · Depuy, Inc. · Mar 1979