Cleared Traditional

K962984 - ISOLA PEDIATRIC COMPONENTS

K962984 is an FDA 510(k) clearance for ISOLA PEDIATRIC COMPONENTS, manufactured by Acromed Corp.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K962984 · Acromed Corp. · Orthopedic device
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Nov 1996
Decision
118d
Days
Class 2
Risk

K962984 is an FDA 510(k) clearance for the ISOLA PEDIATRIC COMPONENTS. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Acromed Corp. (Cleveland, US). The FDA issued a Cleared decision on November 27, 1996 after a review of 118 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 Acromed Corp. devices

FDA 510(k) Submission Details - K962984

510(k) Number K962984 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 01, 1996
Decision Date November 27, 1996
Days to Decision 118 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
4d faster than avg
Panel avg: 122d · This submission: 118d
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 K962984.
ALPHA POSTERIOR SPINAL SYSTEM
K964275 · Sofamor Danek USA,Inc. · Jan 1997
HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM
K962314 · Osteonics Corp. · Dec 1996
CD HORIZON SPINAL SYSTEM
K961633 · Sofamor Danek USA,Inc. · Dec 1996
ACROMED PEDICLE SCREW
K963639 · Acromed Corp. · Nov 1996
COTREL-DUBOUSSET (CD) SPINAL
K955807 · Sofamor Danek USA,Inc. · Oct 1996
COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEM
K955365 · Sofamor Danek USA,Inc. · Mar 1996