Cleared Traditional

K993503 - HAIDER-UCR SPINAL SYSTEM

K993503 is an FDA 510(k) clearance for HAIDER-UCR SPINAL SYSTEM, manufactured by International Advanced Medical Enterprises, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K993503 · International Advanced Medical Enterprises, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
182d
Days
Class 2
Risk

K993503 is an FDA 510(k) clearance for the HAIDER-UCR SPINAL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by International Advanced Medical Enterprises, Inc. (Pleasant Hill, US). The FDA issued a Cleared decision on April 14, 2000 after a review of 182 days - an extended review 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: 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 International Advanced Medical Enterprises, Inc. devices

FDA 510(k) Submission Details - K993503

510(k) Number K993503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1999
Decision Date April 14, 2000
Days to Decision 182 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
60d slower than avg
Panel avg: 122d · This submission: 182d
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 253
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K993503.
PASS SPINAL SYSTEM
K001024 · Encore Orthopedics, Inc. · May 2000
XIA SPINE SYSTEM HOOKS
K001319 · Howmedica Osteonics Corp. · May 2000
COLORADO II SPINAL SYSTEM
K991031 · Sofamor Danek USA,Inc. · May 2000
5.0MM SPINAL SCREWS
K994288 · Ortho Tec, LLC · Apr 2000
COLORADO II SPINAL SYSTEM
K984360 · Sofamor Danek USA,Inc. · Mar 2000
MODIFICATION TO CD SPINAL SYSTEM
K000453 · Medtronic Sofamor Danek, Inc. · Mar 2000