Cleared Traditional

K935567 - SODEM POWER SYSTEM

K935567 is an FDA 510(k) clearance for SODEM POWER SYSTEM, manufactured by Sodemsystems. The device is a Class 1 Orthopedic device with product code HWE cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K935567 · Sodemsystems · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
64d
Days
Class 1
Risk

K935567 is an FDA 510(k) clearance for the SODEM POWER SYSTEM. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Sodemsystems (North Attleboro, US). The FDA issued a Cleared decision on January 21, 1994 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - 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.

FDA 510(k) Submission Details - K935567

510(k) Number K935567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1993
Decision Date January 21, 1994
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

HWE Device Classification - Class 1, General Controls

Product Code HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment

All 74
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K935567.
SNAP DRILL
K935516 · Surgiquip, Inc. · Jan 1994
BONE SAW BLADES
K931176 · Betzler Mfg., Inc. · Jan 1994
ARTHREX AR-8200 SHAVER SYSTEM
K932699 · Arthrex, Inc. · Jan 1994
OSTEON ADAPTOR/CRADLE
K930319 · United American Medical Co., Inc. · Jan 1994
POWERED SURGICAL INSTRUMENT ACCESSORY
K930363 · Intenn Engineering, Inc. · Jan 1994
ACUFEX STERILE DRILLS
K931837 · Acufex Microsurgical, Inc. · Jan 1994
K935567 · SODEM POWER SYSTEM
Download PDF FDA Summary Sodemsystems