Chrysalis Intelligence · Sponsors · Orthonovis, Inc.

Orthonovis, Inc.

Palm Coast, FL, US · 5 510(k) clearances

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Total clearances

5

2022-08-25 → 2025-10-02

Last 12 months

1

Product codes

3

Most recent

2025-10-02

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
HRS	Plate, Fixation, Bone	Class II	Orthopedic	3	2025-03-17
HWC	Screw, Fixation, Bone	Class II	Orthopedic	1	2025-10-02
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Class II	Orthopedic	1	2022-08-25

Filings

All 510(k) clearances (5)

Date	K-number	Device	Code	Class	Specialty
2025-10-02	K252758	Cannulated Screw and Kirschner (K wire) System	HWC	Class II	Orthopedic
2025-03-17	K250498	BPS Wrist Fracture System	HRS	Class II	Orthopedic
2025-02-06	K250055	BPS - Bone Fragment Fixation Plates, Screws and Washers	HRS	Class II	Orthopedic
2024-10-04	K242343	BPS Wrist Fracture System	HRS	Class II	Orthopedic
2022-08-25	K213905	ONX Large External Fixation System	KTT	Class II	Orthopedic