Cleared Traditional

K896106 - ROGOZINSKI SPINAL SYSTEM

K896106 is an FDA 510(k) clearance for ROGOZINSKI SPINAL SYSTEM, manufactured by Richards Medical Co., Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K896106 · Richards Medical Co., Inc. · Orthopedic device
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Jun 1990
Decision
248d
Days
Class 2
Risk

K896106 is an FDA 510(k) clearance for the ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Richards Medical Co., Inc. (Memphis, US). The FDA issued a Cleared decision on June 25, 1990 after a review of 248 days - an extended review 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: 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 Richards Medical Co., Inc. devices

FDA 510(k) Submission Details - K896106

510(k) Number K896106 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 20, 1989
Decision Date June 25, 1990
Days to Decision 248 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 122d · This submission: 248d
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 309
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K896106.
MODULOCK POSTERIOR SPINAL FIXATION
K902397 · Zimmer, Inc. · Nov 1990
DANEK SACRAL HOOK
K901590 · Danek Medical, Inc. · Aug 1990
CHIBA SPINAL SYSTEM
K895978 · Danek Medical, Inc. · Aug 1990
DANEK PRECISION ROD SET
K896254 · Danek Medical, Inc. · Jun 1990
AXIAL AND OFFSET CROSSLINK PLATES
K896740 · Danek Medical, Inc. · Feb 1990
HSC UNIT ROD
K896603 · Danek Medical, Inc. · Jan 1990