Cleared Traditional

K971883 - SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM

K971883 is an FDA 510(k) clearance for SYNTHES SPINE SMALL STATURE ANTERIOR CE..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K971883 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
147d
Days
Class 2
Risk

K971883 is an FDA 510(k) clearance for the SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on October 16, 1997 after a review of 147 days - within the typical 510(k) review window.

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: 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K971883

510(k) Number K971883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1997
Decision Date October 16, 1997
Days to Decision 147 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 122d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

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 586
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K971883.
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K973923 · Ebi Electro Biology · Jan 1998
DEPUY MOTECH PEAK POLYAXIAL ANTERIOR CERVICAL PLATE SYSTEM
K971730 · Depuy, Inc. · Nov 1997
DEPUY MOTECH PROFILE ANTERIOR THORACOLUMBAR PLATE SYSTEM
K973060 · Depuy, Inc. · Nov 1997
M-2 ANTERIOR PLATE SYSTEM
K972718 · Acromed Corp. · Oct 1997
TITANIUM SPINAL ROD SYSTEM
K970635 · Smith & Nephew, Inc., Orthopaedic Div. · Aug 1997
SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS)
K970048 · Synthes (Usa) · Aug 1997