Cleared Traditional

K970950 - EASY ROD

K970950 is an FDA 510(k) clearance for EASY ROD, manufactured by Acromed Corp.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K970950 · Acromed Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
81d
Days
Class 2
Risk

K970950 is an FDA 510(k) clearance for the EASY ROD. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Acromed Corp. (Cleveland, US). The FDA issued a Cleared decision on June 3, 1997 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Acromed Corp. devices

FDA 510(k) Submission Details - K970950

510(k) Number K970950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1997
Decision Date June 03, 1997
Days to Decision 81 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
41d faster than avg
Panel avg: 122d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 170
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K970950.
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
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EBI SPINELINK SYSTEM
K971970 · Electro-Biology, Inc. · Aug 1997
AESUCLAP SOCON SPINAL SYSTEM
K970285 · Aesculap, Inc. · Jun 1997
ACROMED PEDICLE SCREW
K965102 · Acromed Corp. · May 1997
EBI SPINELINK SYSTEM
K964533 · Electro-Biology, Inc. · Apr 1997
ISOLA TWISTER CONNECTOR
K965046 · Acromed Corp. · Mar 1997