Chrysalis Intelligence · Product Codes · GXN

GXN · Unclassified

18 clearances · 10 unique sponsors

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Device class
—
Regulation —
Total clearances
18
2020-01-09 → 2026-06-25
Last 12 months
6
Unique sponsors
10
Classification details
Medical specialty
—
Review panel
—
Regulation number
—
Implant
—
Life-sustain / support
—
GMP exempt
—
Third-party review
—
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Longeviti Neuro Solutions, LLC 7 1 2026-06-25
Fin-Ceramica Faenza S.P.A. 2 0 2024-03-28
Meticuly Co., Ltd. 2 1 2026-01-14
CG Bio Co., Ltd. 1 1 2026-04-09
KLS-Martin L.P. 1 1 2025-11-10
Medcad 1 0 2022-08-26
The Surgeon General, Department of the Army (TSG-DA) 1 1 2026-06-18
Kontour(Xi’An) Medical Technology Co., Ltd. 1 0 2022-10-28
Synthes GmbH 1 1 2025-11-12
Synthes (USA) Products, LLC 1 0 2020-09-18
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
20670 CPT — Medium Cranioplasty with bone graft; non-alterable preformed cranial plates billed under cranioplasty procedures
62000 CPT — Medium Elevation of depressed skull fracture; applicable to cranioplasty with plate fixation
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-06-25 K260709 Longeviti Neuro Solutions ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)
2026-06-18 K253116 The Surgeon General, Department of the Army (TSG-DA) 3D MAC Titanium Cranial Plate (TCP) System
2026-04-09 K252251 CG Bio Co., Ltd. EASYMADE-TI
2026-01-14 K252958 Meticuly Co., Ltd. METICULY Patient-specific titanium mesh implant
2025-11-12 K243715 Synthes GmbH Synthes Patient Specific Implants
2025-11-10 K252573 KLS-Martin L.P. 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
2024-03-28 K240567 Fin-Ceramica Faenza S.P.A. CustomizedBone Service
2023-11-09 K231920 Longeviti Neuro Solutions, LLC Longeviti ClearFit OTS Cranial Implant
2022-10-28 K214109 Kontour(Xi’An) Medical Technology Co., Ltd. PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
2022-08-26 K220357 Medcad MedCAD AccuShape Titanium Patient-Specific Cranial Implant
2021-12-21 K210099 Meticuly Co., Ltd. Meticuly Patient-Specific Titanium Mesh Implant
2021-09-08 K212058 Longeviti Neuro Solutions, LLC Longeviti ClearFit™ OTS Cranial Implants
2021-03-31 K210616 Longeviti Neuro Solutions, LLC Longeviti PMMA Static Cranial Implant
2020-12-16 K203349 Longeviti Neuro Solutions, LLC Longeviti ClearFit Cranial Implant
2020-10-30 K202901 Longeviti Neuro Solutions, LLC Longeviti ClearFit Cranial Implant
2020-09-18 K192702 Synthes (USA) Products, LLC DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional
2020-01-17 K193547 Fin-Ceramica Faenza S.P.A. CustomizedBone Service
2020-01-09 K191210 Longeviti Neuro Solutions, LLC Longeviti ClearFit Cranial Implant
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence