Cleared Traditional

K993030 - MODIFICATION TO ISOLA SPINAL SYSTEM

K993030 is an FDA 510(k) clearance for MODIFICATION TO ISOLA SPINAL SYSTEM, manufactured by Depuyacromed. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K993030 · Depuyacromed · Orthopedic device
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Dec 1999
Decision
113d
Days
Class 2
Risk

K993030 is an FDA 510(k) clearance for the MODIFICATION TO ISOLA SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Depuyacromed (Raynham, US). The FDA issued a Cleared decision on December 29, 1999 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Depuyacromed devices

FDA 510(k) Submission Details - K993030

510(k) Number K993030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1999
Decision Date December 29, 1999
Days to Decision 113 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
9d faster than avg
Panel avg: 122d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 448
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K993030.
ROD TO ROD CROSS BRACES
K000634 · Corin USA · Mar 2000
MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K000513 · Ebi, L.P. · Mar 2000
BONE GRAFT WASHER, MODEL 9090114 - 9090118
K994122 · Danek Medical, Inc. · Feb 2000
K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
K990959 · Spineology, Inc. · Dec 1999
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K993855 · Danek Medical, Inc. · Dec 1999
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K993822 · Ebi, L.P. · Dec 1999