510(k) K243715
- Device
- Synthes Patient Specific Implants
- Applicant
- Synthes GmbH
- 510(k) number
- K243715
- Product code
- GXN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-11-12
- Date received
- 2024-12-02
- Regulation
- 882.5330
- Classification name
- Plate, Cranioplasty, Preformed, Non-Alterable
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Thomas Shea
- Address
- Luzernstrasse 21 Zuchwil CH 4528 4528
FDA Registration Numbers
- 3011423165
- 3009424796
- 2916714
- 3008868758
- 3009582362
- 1825034
- 3007923096
- 3039103971
- 1057946
- 3015531529
- 9610905
- 3010047454
- 3015399803
- 3014279513
- 3004049923
- 3015212339
- 1649518
- 3027157194
- 3015869493
- 9612501
- 3021635140
- 3010407203
- 3008711893
- 3006017180
- 3007738812
- 3015259858
- 9610612
- 3009417901
- 8043792
- 3014680740
- 2011171
- 3000270450
- 2027754
- 3010363503
- 3006130229
- 1032347
- 3014937101
- 3018094310
- 1218882
- 2029275
- 3014483751
- 2029447
- 3008812560
- 3009196021
- 1064858
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code GXN
| 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 |
| 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 - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE | 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(XiAn) 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 |