Cleared Traditional

K083803 - FIXIT HEADREST CLAMP SYSTEM

K083803 is an FDA 510(k) clearance for FIXIT HEADREST CLAMP SYSTEM, manufactured by Medicon EG. The device is a Class 2 Neurology device with product code HBL cleared through the Traditional 510(k) pathway after a 443-day FDA review.

K083803 · Medicon EG · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
443d
Days
Class 2
Risk

K083803 is an FDA 510(k) clearance for the FIXIT HEADREST CLAMP SYSTEM. Classified as Holder, Head, Neurosurgical (skull Clamp) (product code HBL), Class II - Special Controls.

Submitted by Medicon EG (Tuttlingen, DE). The FDA issued a Cleared decision on March 10, 2010 after a review of 443 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4460 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

FDA 510(k) Submission Details - K083803

510(k) Number K083803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2008
Decision Date March 10, 2010
Days to Decision 443 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
294d slower than avg
Panel avg: 149d · This submission: 443d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBL Device Classification - Class 2, Special Controls

Product Code HBL Holder, Head, Neurosurgical (skull Clamp)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4460
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 Neurology devices follow this clearance model.

Regulatory Peers - HBL Holder, Head, Neurosurgical (skull Clamp)

All 46
Devices cleared under the same product code (HBL) and FDA review panel - the closest regulatory comparables to K083803.
MAYFIELD SKULL CLAMP
K120633 · Integra LifeSciences Corporation · May 2012
IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)
K113748 · Imris, Inc. · Mar 2012
HEAD FIATION DEVICE (HFD 100)
K103493 · Imris, Inc. · Mar 2011
HEAD FIXATION ARC AND TABLE BASE
K091439 · Surgivision, Inc. · Aug 2009
DINKLER SURGICAL SKULL CLAMP, MODEL 0308
K090695 · Dinkler Surgical Devices, Inc. · Apr 2009
MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114
K090506 · Integra LifeSciences Corporation · Apr 2009