Cleared Traditional

K992000 - SYNTHES CRANIAL FLAP TUBE CLAMP

K992000 is an FDA 510(k) clearance for SYNTHES CRANIAL FLAP TUBE CLAMP, manufactured by Synthes (Usa). The device is a Class 2 Neurology device with product code GXN cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K992000 · Synthes (Usa) · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
35d
Days
Class 2
Risk

K992000 is an FDA 510(k) clearance for the SYNTHES CRANIAL FLAP TUBE CLAMP. Classified as Plate, Cranioplasty, Preformed, Non-alterable (product code GXN), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on July 20, 1999 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5330 - 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: 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K992000

510(k) Number K992000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1999
Decision Date July 20, 1999
Days to Decision 35 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
113d faster than avg
Panel avg: 148d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXN Device Classification - Class 2, Special Controls

Product Code GXN Plate, Cranioplasty, Preformed, Non-alterable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5330
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 - GXN Plate, Cranioplasty, Preformed, Non-alterable

All 55
Devices cleared under the same product code (GXN) and FDA review panel - the closest regulatory comparables to K992000.
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K991029 · Walter Lorenz Surgical, Inc. · Apr 1999
SEVRAIN CRANIAL CLAMP
K971252 · Ikonos Corp. · Jul 1998
SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)
K971408 · Ikonos Corp. · May 1998