Plate, Cranioplasty, Preformed, Non-Alterable

GXN 2026-06-18

3D MAC Titanium Cranial Plate (TCP) System

Applicant The Surgeon General, Department of the Army (TSG-DA)

K number K253116

GXN 2026-04-09

EASYMADE-TI

Applicant CG Bio Co., Ltd.

K number K252251

GXN 2026-01-14

METICULY Patient-specific titanium mesh implant

Applicant Meticuly Co., Ltd.

K number K252958

GXN 2025-11-12

Synthes Patient Specific Implants

Applicant Synthes GmbH

K number K243715

GXN 2025-11-10

KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

Applicant KLS-Martin L.P.

K number K252573

GXN 2024-03-28

CustomizedBone Service

K number K240567

GXN 2023-11-09

Longeviti ClearFit OTS Cranial Implant

K number K231920

GXN 2022-10-28

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)

Applicant Kontour(Xi’An) Medical Technology Co., Ltd.

K number K214109

GXN 2022-08-26

MedCAD AccuShape Titanium Patient-Specific Cranial Implant

Applicant Medcad

K number K220357

GXN 2021-12-21

Meticuly Patient-Specific Titanium Mesh Implant

Applicant Meticuly Co., Ltd.

K number K210099

GXN 2021-09-08

Longeviti ClearFit™ OTS Cranial Implants

K number K212058

GXN 2021-03-31

Longeviti PMMA Static Cranial Implant

K number K210616

GXN 2020-12-16

Longeviti ClearFit Cranial Implant

K number K203349

GXN 2020-10-30

Longeviti ClearFit Cranial Implant

K number K202901

GXN 2020-09-18

DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional

Applicant Synthes (USA) Products, LLC

K number K192702

GXN 2020-01-17

CustomizedBone Service

K number K193547

GXN 2020-01-09

Longeviti ClearFit Cranial Implant

K number K191210

GXN 2018-07-27

OsteoFab Patient Specific Cranial Device

Applicant Oxford Performance Materials, Inc.

K number K180064

GXN 2018-05-15

CustomizedBone Service

K number K180513

GXN 2018-03-23

Longeviti PMMA Static Cranial Implant

K number K170410

GXN 2017-09-01

CustomizedBone Service

K number K171507

GXN 2017-01-19

Cranial PSI

Applicant Ossdsign AB

K number K161090

GXN 2016-12-17

CustomizedBone Service

K number K160707

GXN 2013-02-07

OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE

Applicant Oxford Performance Materials

K number K121818

GXN 2012-09-25

CUSTOM CRANIOFACIAL IMPLANT (CCI)

Applicant Kelyniam Global, Inc.

K number K121755

GXN 2012-08-30

CRAINFIX 2 TITANIUM CLAMP SYSTEM

Applicant Aesculap, Inc.

K number K122353

GXN 2012-08-08

OSTEOSYMBIONICS PEEK CRANIAL IMPLANT

Applicant Osteosymbionics, LLC

K number K121102

GXN 2011-06-24

MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT

Applicant Vanduzen Dba Medcad

K number K110684

GXN 2011-04-14

KELYNIAM CUSTOM SKULL IMPLANT (CSI)

Applicant Kelyniam Global, Inc.

K number K103582

GXN 2008-08-13

MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION

Applicant Bioplate, Inc.

K number K082175

GXN 2007-12-19

PATIENT CONTOURED MESH-PEEK (PCM-P)

Applicant KLS-Martin L.P.

K number K072707

GXN 2007-06-15

MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM

Applicant Bioplate, Inc.

K number K070901

GXN 2006-12-04

BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY

Applicant Bioplate, Inc.

K number K062819

GXN 2006-11-22

KLS MARTIN QUICK DISC

Applicant KLS Martin L.P.

K number K062857

GXN 2006-10-31

PATIENT CONTOURED MESH (PCM)

Applicant KLS-Martin L.P.

K number K062570

GXN 2005-12-16

STRYKER CUSTOM TI IMPLANT

Applicant Stryker Leibinger

K number K052871

GXN 2005-12-14

SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT

Applicant Synthes (Usa)

K number K053199

GXN 2004-06-21

SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS

Applicant Synthes (Usa)

K number K033868

GXN 2004-06-17

CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM

Applicant Aesculap

K number K040864

GXN 2003-05-21

SPIN DOWN RAPIDFLAP

Applicant Walter Lorenz Surgical, Inc.

K number K031034

GXN 2003-04-01

OSTEOMED CRANIAL FLAP FIXATION SYSTEM

Applicant Osteomed Corp.

K number K022277

GXN 2003-03-20

STRYKER LEIBINGER CRANIAL FIXATION SYSTEM

Applicant Stryker Instruments

K number K030378

GXN 2002-02-08

MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM

Applicant Bioplate, Inc.

K number K020088

GXN 2001-12-10

THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM

Applicant Bioplate, Inc.

K number K013050

GXN 2001-12-05

MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520

Applicant Medtronic Neurosurgery

K number K013000

GXN 2000-02-22

LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM

Applicant Stryker Instruments

K number K993990

GXN 1999-07-20

SYNTHES CRANIAL FLAP TUBE CLAMP

Applicant Synthes (Usa)

K number K992000

GXN 1999-07-20

SYNTHES CRANIAL FLAP TWIST CLAMP

Applicant Synthes (Usa)

K number K991860

GXN 1999-04-23

RAPIDFLAP CRANIAL CLAMP

Applicant Walter Lorenz Surgical, Inc.

K number K991029

GXN 1998-07-06

SEVRAIN CRANIAL CLAMP

Applicant Ikonos Corp.

K number K971252

GXN 1998-05-12

SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)

Applicant Ikonos Corp.

K number K971408

GXN 1998-01-16

AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM

Applicant Aesculap, Inc.

K number K972332