GXN · Class II · 21 CFR 882.5330

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

Leading manufacturers include Longeviti Neuro Solutions, LLC, KLS-Martin L.P. and Synthes (Usa).

57
Total
57
Cleared
155d
Avg days
1998
Since
57 devices
25–48 of 57
Cleared Oct 31, 2006
PATIENT CONTOURED MESH (PCM)
K062570
KLS-Martin L.P.
Neurology · 61d
Cleared Dec 14, 2005
SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT
K053199
Synthes (Usa)
Neurology · 28d
Cleared Jun 21, 2004
SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS
K033868
Synthes (Usa)
Neurology · 192d
Cleared May 21, 2003
SPIN DOWN RAPIDFLAP
K031034
Walter Lorenz Surgical, Inc.
Neurology · 50d
Cleared Mar 20, 2003
STRYKER LEIBINGER CRANIAL FIXATION SYSTEM
K030378
Stryker Instruments
Neurology · 43d
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 Jan 16, 1998
AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM
K972332
Aesculap, Inc.
Neurology · 207d