What is FDA product code OJH?

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

General & Plastic Surgery › SurgicalOrthopedic Tray

Falco Fusion System Surgical Instruments Tray (Full)

Name: Falco Fusion System Surgical Instruments Tray (Full)
Brand: Falco Fusion System Surgical Instruments Tray (Full)

Reusable surgical instrument tray containing instruments used with the Falco Fusion System for sacroiliac joint fusion procedures.

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code OJH
Manufacturer	City	Province	Registered as	Device types
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71

Record

Regulatory record for Falco Fusion System Surgical Instruments Tray (Full)
Listed by	McNicoll Chirurgical Inc.
FDA product code	OJH
Device type	Orthopedic Tray
Device class	Class 1
Regulation	21 CFR 878.4800
510(k)	K253611
Record published	2026-03-27

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Falco Fusion System Surgical Instruments Tray (Full)
Catalogue number	Size	Status
450-001		In distribution

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Showing 12 of 367. All products under Orthopedic Tray

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.