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

OSSIOfiber® Trimmable Fixation Nail System

Name: OSSIOfiber® Trimmable Fixation Nail System
Brand: OSSIOfiber® Trimmable Fixation Nail System

OSSIOfiber® Trimmable Fixation Nail System, 4.0x50mm. Package contains: 2 Implants, 1 Insertion Sleeve, 1 Bone Tamp, 1 Depth Gauge, 2 K-Wires, 1 Cannulated Drill Bit.

Registry build 21.09.26

1manufacturer

4catalogue numbers in this listing

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 OSSIOfiber® Trimmable Fixation Nail System
Listed by	Ossio Ltd., Israel
FDA product code	OJH
Device type	Orthopedic Tray
Device class	Class 1
Regulation	21 CFR 878.4800
Establishment	Specification developer, Manufacturer, Exporter
Record published	2020-06-15
Record revised	2023-09-18 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Special storage condition: Do not expose product to temperatures greater than 47°C or 116°F; Storage environment temperature 7 to 30 °C; Special storage condition: Keep dry; Special storage condition: Store at a normal relative humidity
Sizes	Length 30 to 50 mm; outer diameter 2.4 to 4 mm

Catalogue Numbers

Catalogue numbers for OSSIOfiber® Trimmable Fixation Nail System
Catalogue number	Size	Status
OF2012450S	Length 50 mm	In distribution
OF2012430S	Length 30 mm	In distribution
OF2044050S	Length 50 mm	In distribution
OF2014050S	Length 50 mm	In distribution

Same Product Code

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Halyard	Avid Medical, Inc.	1,313
Aligned Medical Solutions	Aligned Medical Solutions	1,272
Regard™	ROi CPS LLC	464
Overwatch	Spinal Elements, Inc.	223
Regard™	Resource Optimization & Innovation, L.L.C.	191
Lucent L	Spinal Elements, Inc.	95
Invenio	GRI Medical & Electronic Technology Co., Ltd.	87
Integra®	Ascension Orthopedics, Inc.	81

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.