Cleared Traditional

K843687 - ROD FOR RACHIS SURGERY

K843687 is an FDA 510(k) clearance for ROD FOR RACHIS SURGERY, manufactured by Sofamor Co.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K843687 · Sofamor Co. · Orthopedic device
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Jan 1985
Decision
114d
Days
Class 2
Risk

K843687 is an FDA 510(k) clearance for the ROD FOR RACHIS SURGERY. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Sofamor Co. (Greensburg, US). The FDA issued a Cleared decision on January 10, 1985 after a review of 114 days - within the typical 510(k) review window.

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 Sofamor Co. devices

FDA 510(k) Submission Details - K843687

510(k) Number K843687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1984
Decision Date January 10, 1985
Days to Decision 114 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 122d · This submission: 114d
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 354
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K843687.
MARTIN LAMINAR OSTEOSYNTHESIS SYSTEM
K854770 · Advanced Biosearch Assn. · Feb 1986
KIRSCHNER SPINAL PRODUCT SYSTEM
K854524 · Kirschner Medical Corp. · Dec 1985
EDWARDS SACRAL SCREW
K851935 · Zimmer, Inc. · Jun 1985
HARRINGTON-TYPE INSTRU-SCOLIOSIS
K840423 · Link America, Inc. · Mar 1984
DEPUY SEGMENTALSPINAL SYSTEM
K810329 · Depuy, Inc. · Apr 1981
ARMSTRONG SPINAL APPLIANCE
K810224 · Howmedica Corp. · Feb 1981