Product code GXN
- Device name
- Plate, Cranioplasty, Preformed, Non-Alterable
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.5330
- Review panel
- NE
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252251 | EASYMADE-TI | CG Bio Co., Ltd. | 2026-04-09 |
| K252958 | METICULY Patient-specific titanium mesh implant | Meticuly Co., Ltd. | 2026-01-14 |
| K243715 | Synthes Patient Specific Implants | Synthes GmbH | 2025-11-12 |
| K252573 | 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... | KLS-Martin L.P. | 2025-11-10 |
| K240567 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | 2024-03-28 |
| K231920 | Longeviti ClearFit OTS Cranial Implant | Longeviti Neuro Solutions, LLC | 2023-11-09 |
| K214109 | PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) | Kontour(Xi’An) Medical Technology Co., Ltd. | 2022-10-28 |
| K220357 | MedCAD AccuShape Titanium Patient-Specific Cranial Implant | Medcad | 2022-08-26 |
| K210099 | Meticuly Patient-Specific Titanium Mesh Implant | Meticuly Co., Ltd. | 2021-12-21 |
| K212058 | Longeviti ClearFit™ OTS Cranial Implants | Longeviti Neuro Solutions, LLC | 2021-09-08 |
| K210616 | Longeviti PMMA Static Cranial Implant | Longeviti Neuro Solutions, LLC | 2021-03-31 |
| K203349 | Longeviti ClearFit Cranial Implant | Longeviti Neuro Solutions, LLC | 2020-12-16 |
| K202901 | Longeviti ClearFit Cranial Implant | Longeviti Neuro Solutions, LLC | 2020-10-30 |
| K192702 | DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional | Synthes (USA) Products, LLC | 2020-09-18 |
| K193547 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | 2020-01-17 |
| K191210 | Longeviti ClearFit Cranial Implant | Longeviti Neuro Solutions, LLC | 2020-01-09 |
| K180064 | OsteoFab Patient Specific Cranial Device | Oxford Performance Materials, Inc. | 2018-07-27 |
| K180513 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | 2018-05-15 |
| K170410 | Longeviti PMMA Static Cranial Implant | Longeviti Neuro Solutions, LLC | 2018-03-23 |
| K171507 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | 2017-09-01 |
| K161090 | Cranial PSI | Ossdsign AB | 2017-01-19 |
| K160707 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | 2016-12-17 |
| K151692 | BioArchitects Patient Specific Cranial/Craniofacial Plate | Bioarchitects USA, LLC | 2015-11-20 |
| K151382 | Patient Contoured Implant-PEEK (PCI-PEEK) | KLS Martin L.P. | 2015-11-09 |
| K130447 | SPEEDY FLAP SYSTEM | Jeil Medical Corporation | 2014-12-22 |
| K133082 | OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE | Osteosymbionics, LLC | 2014-05-20 |
| K121818 | OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE | Oxford Performance Materials | 2013-02-07 |
| K121755 | CUSTOM CRANIOFACIAL IMPLANT (CCI) | Kelyniam Global, Inc. | 2012-09-25 |
| K122353 | CRAINFIX 2 TITANIUM CLAMP SYSTEM | Aesculap, Inc. | 2012-08-30 |
| K121102 | OSTEOSYMBIONICS PEEK CRANIAL IMPLANT | Osteosymbionics, LLC | 2012-08-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810188324689 | HTR-PEKK | OXFORD PERFORMANCE MATERIALS, INC. | 2026-06-03 |
| 00810188324665 | HTR-PEKK | OXFORD PERFORMANCE MATERIALS, INC. | 2026-06-01 |
| 00810188324641 | HTR-PEKK | OXFORD PERFORMANCE MATERIALS, INC. | 2026-05-28 |
| 00810188324658 | HTR-PEKK | OXFORD PERFORMANCE MATERIALS, INC. | 2026-05-28 |
| 00810188324634 | HTR-PEKK | OXFORD PERFORMANCE MATERIALS, INC. | 2026-05-27 |
| 08859751216435 | METICULY Patient-specific titanium mesh implant | METICULY COMPANY LIMITED | 2026-03-05 |
| 08859751216442 | METICULY Patient-specific titanium mesh implant | METICULY COMPANY LIMITED | 2026-03-05 |
| 08859751216428 | METICULY Patient-specific titanium mesh implant | METICULY COMPANY LIMITED | 2026-03-05 |
| 08859751216411 | METICULY Patient-specific titanium mesh implant | METICULY COMPANY LIMITED | 2026-03-05 |
| 08859751216343 | METICULY Patient-specific titanium mesh implant | METICULY COMPANY LIMITED | 2026-03-05 |
| 08859751216336 | METICULY Patient-specific titanium mesh implant | METICULY COMPANY LIMITED | 2026-03-05 |
| 08859751216312 | METICULY Patient-specific titanium mesh implant | METICULY COMPANY LIMITED | 2026-03-05 |
| 08859751216206 | METICULY Patient-specific titanium mesh implant | METICULY COMPANY LIMITED | 2026-03-05 |
| 08859751210570 | METICULY Patient-specific titanium mesh implant | METICULY COMPANY LIMITED | 2026-03-05 |
| 08859751210563 | METICULY Patient-specific titanium mesh implant | METICULY COMPANY LIMITED | 2026-03-05 |
| 08859751210556 | METICULY Patient-specific titanium mesh implant | METICULY COMPANY LIMITED | 2026-03-05 |
| 08859751216329 | METICULY Patient-specific titanium mesh implant | METICULY COMPANY LIMITED | 2026-03-05 |
| M3848135160 | Bioplate® | Bioplate, Inc. | 2015-12-03 |
| M3848135170 | Bioplate® | Bioplate, Inc. | 2015-12-03 |
| M3848135180 | Bioplate® | Bioplate, Inc. | 2015-12-03 |
| 10887587054834 | NA | Synthes GmbH | 2015-09-14 |
| 10887587054827 | NA | Synthes GmbH | 2015-09-14 |
| 10887587054810 | NA | Synthes GmbH | 2015-09-14 |
| 10887587054803 | NA | Synthes GmbH | 2015-09-14 |
| 10887587054797 | NA | Synthes GmbH | 2015-09-14 |
| 10887587054780 | NA | Synthes GmbH | 2015-09-14 |
| 10887587054773 | NA | Synthes GmbH | 2015-09-14 |
| 10887587054766 | NA | Synthes GmbH | 2015-09-14 |
| 10887587054759 | NA | Synthes GmbH | 2015-09-14 |
| 10887587054742 | NA | Synthes GmbH | 2015-09-14 |