JEY · Plate, Bone · Chrysalis Intelligence

Device class

Class II

Regulation 872.4760

Total clearances

2020-03-26 → 2026-07-25

Last 12 months

Unique sponsors

Classification details

Medical specialty

Dental

Review panel

Regulation number

872.4760

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
Stryker Leibinger GmbH & Co KG	3	0	2024-07-12
KLS-Martin L.P.	2	0	2024-08-16
Medcad	2	0	2023-09-26
Stryker	2	0	2020-03-26
Meticuly Co., Ltd.	2	1	2026-07-25
Southern Medical (Pty) , Ltd.	1	1	2025-12-19
Industrias Medicas Sampedro S.A.S	1	0	2021-05-19
Stryker Craniomaxillofacial (Cmf)	1	0	2022-12-09
Biomet Microfixation	1	0	2021-08-05
Faico Medical, LLC	1	0	2020-04-22
Stryker Craniomaxillofacial	1	0	2024-01-13
Stryker Leibinger Micro Implants	1	0	2022-02-04
Synthes (USA) Products, LLC	1	0	2020-09-10
Techmah Cmf	1	0	2024-07-11
Sites Medical, LLC	1	0	2021-07-14
Reoss GmbH	1	0	2020-06-17
Jeil Medical Corporation	1	1	2026-04-02
Microware Precision Co., Ltd.	1	0	2022-11-10
Inion OY	1	1	2025-11-07
Montjade Engineering Co., Ltd.	1	0	2020-07-29

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.

Code	Type	Description	Confidence	Rationale
D6064	CPT	—	Medium	CDT code for dental bone plate/graft; some insurers use CPT 21080

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-25	K253206	Meticuly Co., Ltd.	METICULY Patient-specific CMF solution
2026-04-02	K252246	Jeil Medical Corporation	Leforte MMF System
2025-12-19	K253373	Southern Medical (Pty) , Ltd.	Southern Craniomaxillofacial (CMF) System
2025-11-07	K251441	Inion OY	Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
2024-08-16	K241314	KLS-Martin L.P.	KLS Martin Oral-Max Implants MR Conditional (bundled)
2024-07-12	K240651	Stryker Leibinger GmbH & Co KG	MRI Universal
2024-07-11	K233874	Techmah Cmf	tmCMF Solution
2024-04-30	K232889	Meticuly Co., Ltd.	METICULY Patient-specific titanium maxillofacial mesh implant
2024-01-13	K232350	Stryker Craniomaxillofacial	Stryker Facial iD System
2023-09-26	K230398	Medcad	MedCAD® AccuPlate® 3DTi Patient-Specific Plating System
2023-08-05	K230733	Stryker Leibinger GmbH & Co KG	Stryker Resorbable Fixation System
2022-12-09	K222650	Stryker Craniomaxillofacial (Cmf)	Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate
2022-11-10	K220360	Microware Precision Co., Ltd.	Tandry CMF Plate System
2022-11-09	K221855	Stryker Leibinger GmbH & Co KG	Universal CMF System
2022-07-18	K210731	KLS-Martin L.P.	KLS Martin Individual Patient Solutions
2022-02-04	K213777	Stryker Leibinger Micro Implants	Stryker Resorbable Fixation System
2021-08-05	K202969	Biomet Microfixation	Biomet Microfixation OmniMax MMF System
2021-07-14	K202918	Sites Medical, LLC	OsteoSync Ti Dental Mesh
2021-05-19	K203282	Industrias Medicas Sampedro S.A.S	TECHFIT Patient-Specific Maxillofacial System
2021-02-12	K193280	Medcad	MedCAD® AccuPlate® Patient-Specific Plate
2020-09-10	K201944	Synthes (USA) Products, LLC	DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
2020-07-29	K182759	Montjade Engineering Co., Ltd.	BoniPlus Dental G-Mesh System
2020-06-17	K192747	Reoss GmbH	Yxoss CBR®
2020-04-22	K191997	Faico Medical, LLC	FAICO CMF System
2020-03-26	K193143	Stryker	Stryker Facial iD Plating System