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)
Top companies in GXN
| Company | 510(k)s | Recalls |
|---|---|---|
| Longeviti Neuro Solutions | 8 | 0 |
| Kelyniam Global, Inc. | 2 | 4 |
| Zimmer Biomet, Inc. | 0 | 6 |
| Bioplate, Inc. | 5 | 0 |
| Fin-Ceramica Faenza S.P.A. | 5 | 0 |
| KLS Martin L.P. | 5 | 0 |
| Synthes (Usa) | 5 | 0 |
| Aesculap | 3 | 0 |
| Ikonos Corp. | 2 | 0 |
| Meticuly Co., Ltd. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 25, 2026 | K260709 | ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring Longeviti Neuro Solutions | GXN |
| Jun 18, 2026 | K253116 | 3D MAC Titanium Cranial Plate (TCP) System The Surgeon General, Department of the Army (TSG-DA) | GXN |
| Apr 9, 2026 | K252251 | EASYMADE-TI CG Bio Co., Ltd., KR | GXN |
| Jan 14, 2026 | K252958 | METICULY Patient-specific titanium mesh implant Meticuly Co., Ltd., TH | GXN |
| Nov 12, 2025 | K243715 | Synthes Patient Specific Implants Synthes GmbH, CH | GXN |
| Nov 10, 2025 | K252573 | KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Mart KLS-Martin L.P. | GXN |
| Mar 28, 2024 | K240567 | CustomizedBone Service Fin-Ceramica Faenza S.P.A., IT | GXN |
| Nov 9, 2023 | K231920 | Longeviti ClearFit OTS Cranial Implant Longeviti Neuro Solutions, LLC | GXN |
| Oct 28, 2022 | K214109 | PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) Kontour(XiAn) Medical Technology Co., Ltd., CN | GXN |
| Aug 26, 2022 | K220357 | MedCAD AccuShape Titanium Patient-Specific Cranial Implant Medcad | GXN |
| Dec 21, 2021 | K210099 | Meticuly Patient-Specific Titanium Mesh Implant Meticuly Co., Ltd., TH | GXN |
| Sep 8, 2021 | K212058 | Longeviti ClearFit OTS Cranial Implants Longeviti Neuro Solutions, LLC | GXN |
| Mar 31, 2021 | K210616 | Longeviti PMMA Static Cranial Implant Longeviti Neuro Solutions, LLC | GXN |
| Dec 16, 2020 | K203349 | Longeviti ClearFit Cranial Implant Longeviti Neuro Solutions, LLC | GXN |
| Oct 30, 2020 | K202901 | Longeviti ClearFit Cranial Implant Longeviti Neuro Solutions, LLC | GXN |
| Sep 18, 2020 | K192702 | DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional Synthes (USA) Products, LLC | GXN |
| Jan 17, 2020 | K193547 | CustomizedBone Service Fin-Ceramica Faenza S.P.A., IT | GXN |
| Jan 9, 2020 | K191210 | Longeviti ClearFit Cranial Implant Longeviti Neuro Solutions, LLC | GXN |
| Jul 27, 2018 | K180064 | OsteoFab Patient Specific Cranial Device Oxford Performance Materials, Inc. | GXN |
| May 15, 2018 | K180513 | CustomizedBone Service Fin-Ceramica Faenza S.P.A., IT | GXN |
| Mar 23, 2018 | K170410 | Longeviti PMMA Static Cranial Implant Longeviti Neuro Solutions, LLC | GXN |
| Sep 1, 2017 | K171507 | CustomizedBone Service Fin-Ceramica Faenza S.P.A., IT | GXN |
| Jan 19, 2017 | K161090 | Cranial PSI Ossdsign AB, SE | GXN |
| Dec 17, 2016 | K160707 | CustomizedBone Service Fin-Ceramica Faenza S.P.A., IT | GXN |
| Nov 20, 2015 | K151692 | BioArchitects Patient Specific Cranial/Craniofacial Plate Bioarchitects USA, LLC | GXN |
| Nov 9, 2015 | K151382 | Patient Contoured Implant-PEEK (PCI-PEEK) KLS Martin L.P. | GXN |
| Dec 22, 2014 | K130447 | SPEEDY FLAP SYSTEM Jeil Medical Corporation, KR | GXN |
| May 20, 2014 | K133082 | OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE Osteosymbionics, LLC | GXN |
| Feb 7, 2013 | K121818 | OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE Oxford Performance Materials | GXN |
| Sep 25, 2012 | K121755 | CUSTOM CRANIOFACIAL IMPLANT (CCI) Kelyniam Global, Inc. | GXN |
| Aug 30, 2012 | K122353 | CRAINFIX 2 TITANIUM CLAMP SYSTEM Aesculap, Inc. | GXN |
| Aug 8, 2012 | K121102 | OSTEOSYMBIONICS PEEK CRANIAL IMPLANT Osteosymbionics, LLC | GXN |
| Jun 24, 2011 | K110684 | MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT Vanduzen Dba Medcad | GXN |
| Apr 14, 2011 | K103582 | KELYNIAM CUSTOM SKULL IMPLANT (CSI) Kelyniam Global, Inc. | GXN |
| Aug 13, 2008 | K082175 | MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION Bioplate, Inc. | GXN |
| Dec 19, 2007 | K072707 | PATIENT CONTOURED MESH-PEEK (PCM-P) KLS-Martin L.P. | GXN |
| Jun 15, 2007 | K070901 | MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM Bioplate, Inc. | GXN |
| Dec 4, 2006 | K062819 | BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Bioplate, Inc. | GXN |
| Nov 22, 2006 | K062857 | KLS MARTIN QUICK DISC KLS Martin L.P. | GXN |
| Oct 31, 2006 | K062570 | PATIENT CONTOURED MESH (PCM) KLS-Martin L.P. | GXN |
| Dec 16, 2005 | K052871 | STRYKER CUSTOM TI IMPLANT Stryker Leibinger | GXN |
| Dec 14, 2005 | K053199 | SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT Synthes (Usa) | GXN |
| Jun 21, 2004 | K033868 | SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS Synthes (Usa) | GXN |
| Jun 17, 2004 | K040864 | CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM Aesculap | GXN |
| May 21, 2003 | K031034 | SPIN DOWN RAPIDFLAP Walter Lorenz Surgical, Inc. | GXN |
| Apr 1, 2003 | K022277 | OSTEOMED CRANIAL FLAP FIXATION SYSTEM Osteomed Corp. | GXN |
| Mar 20, 2003 | K030378 | STRYKER LEIBINGER CRANIAL FIXATION SYSTEM Stryker Instruments | GXN |
| Feb 8, 2002 | K020088 | MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM Bioplate, Inc. | GXN |
| Dec 10, 2001 | K013050 | THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM Bioplate, Inc. | GXN |
| Dec 5, 2001 | K013000 | MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520 Medtronic Neurosurgery | GXN |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.