ClearanceBrief
Panels › Neurology › Product code GXN · Class 2

Plate, Cranioplasty, Preformed, Non-Alterable

Regulation 882.5330

6510(k)s in 12 months (57 all time)
0recalls in 12 months (11 all time)
11recalls that name a 510(k)
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Top companies in GXN

Company510(k)sRecalls
Longeviti Neuro Solutions80
Kelyniam Global, Inc.24
Zimmer Biomet, Inc.06
Bioplate, Inc.50
Fin-Ceramica Faenza S.P.A.50
KLS Martin L.P.50
Synthes (Usa)50
Aesculap30
Ikonos Corp.20
Meticuly Co., Ltd.20
DateFirm and productCodeLinked 510(k)
Aug 22, 2018Zimmer Biomet, Inc.
Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1040-12 Used for the re-attachment of the bone flap after a craniotomy.
Terminated		 GXNK031034
Aug 22, 2018Zimmer Biomet, Inc.
Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp Ref Number: 75-1040 Used for the re-attachment of the bone flap after a craniotomy.
Terminated		 GXNK031034
Aug 22, 2018Zimmer Biomet, Inc.
Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1030-12 Used for the re-attachment of the bone flap after a craniotomy.
Terminated		 GXNK031034
Aug 22, 2018Zimmer Biomet, Inc.
Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp Ref Number: 75-1030 Used for the re-attachment of the bone flap after a craniotomy.
Terminated		 GXNK031034
Aug 22, 2018Zimmer Biomet, Inc.
Biomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1020-12 Used for the re-attachment of the bone flap after a craniotomy.
Terminated		 GXNK031034
Aug 22, 2018Zimmer Biomet, Inc.
Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020 Used for the re-attachment of the bone flap after a craniotomy.
Terminated		 GXNK031034
Jun 10, 2017Kelyniam Global, Inc.
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004
Terminated		 GXNK103582
Jun 10, 2017Kelyniam Global, Inc.
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003
Terminated		 GXNK103582
Jun 10, 2017Kelyniam Global, Inc.
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002
Terminated		 GXNK103582
Jun 10, 2017Kelyniam Global, Inc.
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
Terminated		 GXNK103582
Sep 23, 2015Synthes (USA) Products LLC
Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotom
Terminated		 GXNK992000

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