Cleared Traditional

K983530 - SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM

K983530 is an FDA 510(k) clearance for SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM, manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K983530 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
69d
Days
Class 2
Risk

K983530 is an FDA 510(k) clearance for the SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on December 16, 1998 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K983530

510(k) Number K983530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1998
Decision Date December 16, 1998
Days to Decision 69 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
53d faster than avg
Panel avg: 122d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 376
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K983530.
SYNTHES SPINE CERVIFIX SYSTEM
K984377 · Synthes (Usa) · Jan 1999
ROGOZINSKI SPINAL ROD SYSTEM
K983904 · United States Surgical, A Division of Tyco Healthc · Dec 1998
SCS SPINAL SYSTEM
K983353 · Orthotec, Inc. · Dec 1998
DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMS
K983583 · Depuy, Inc. · Dec 1998
SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEM
K982322 · Synthes (Usa) · Nov 1998
OMI OCCIPITAL CERVICAL LOOP, MODEL A1089
K983282 · Ohio Medical Instrument Co., Inc. · Nov 1998