GXN · Class II · 21 CFR 882.5330

FDA Product Code GXN: Plate, Cranioplasty, Preformed, Non-alterable

Leading manufacturers include Longeviti Neuro Solutions, LLC, Fin-Ceramica Faenza S.P.A. and Bioplate, Inc..

57
Total
57
Cleared
155d
Avg days
1998
Since
57 devices
49–57 of 57
Cleared Feb 22, 2000
LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM
K993990
Stryker Instruments
Neurology · 90d
Cleared Jul 20, 1999
SYNTHES CRANIAL FLAP TWIST CLAMP
K991860
Synthes (Usa)
Neurology · 49d
Cleared Jul 20, 1999
SYNTHES CRANIAL FLAP TUBE CLAMP
K992000
Synthes (Usa)
Neurology · 35d
Cleared Apr 23, 1999
RAPIDFLAP CRANIAL CLAMP
K991029
Walter Lorenz Surgical, Inc.
Neurology · 25d
Cleared Jul 06, 1998
SEVRAIN CRANIAL CLAMP
K971252
Ikonos Corp.
Neurology · 459d
Cleared May 12, 1998
SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)
K971408
Ikonos Corp.
Neurology · 391d
Cleared Jan 16, 1998
AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM
K972332
Aesculap, Inc.
Neurology · 207d