What is FDA product code OCJ?

Create channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA) prior to a vertebroplasty procedure. Treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions, and/or malignant lesions.

Orthopedic › SurgicalSpinal Channeling Instrument, Vertebroplasty

Main-AXS Needle-Spinal Simplicity

Name: Main-AXS Needle-Spinal Simplicity
Brand: Main-AXS Needle-Spinal Simplicity

Single Use, Bone Access Needle, Sterile Blunt Stylus & Blunt Cannula with Extra Trocar Stylus

Registry build 21.09.26

5manufacturers in China registered for this device type

2catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Beijing (1), Jiangsu (1).

Chinese manufacturers registered for FDA product code OCJ
Manufacturer	City	Province	Registered as	Device types
Shanghai Medical Instruments (Group) Ltd. Corp.	Shanghai	Shanghai	Contract manufacturer	235
Beijing Fule Science & Technology Development Co., Ltd.	Beijing	Beijing	Manufacturer	31
Shanghai Lange Medtech Co., Ltd.	Shanghai	Shanghai	Manufacturer	16
Jiangsu Changmei Medtech Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	8
Ningbo Hicren Biotechnology Co., Ltd.	Ningbo	Zhejiang	Manufacturer	5

Record

Regulatory record for Main-AXS Needle-Spinal Simplicity
Listed by	Mainstream Medical Devices, United States
FDA product code	OCJ
Device type	Spinal Channeling Instrument, Vertebroplasty
Device class	Class 1
Regulation	21 CFR 888.4540
Establishment	Contract manufacturer, Contract steriliser, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2024-12-03

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Sizes	Needle gauge 8 to 11 G; length 6 to 7 in

Catalogue Numbers

Catalogue numbers for Main-AXS Needle-Spinal Simplicity
Catalogue number	Size	Status
299-08-900	Needle Gauge 8 G	In distribution
292-11-920	Needle Gauge 11 G	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Biopsybell	Biopsybell SRL	25
Biopsybell SRL	Biopsybell SRL	9
V-Access	G21 SRL	6
Capo Needle	Nexone BIO Co., Ltd.	5
Spinal Channeling Instrument, Vertebroplasty	Stryker GmbH	3
Bone Drills	Shanghai Lange Medtech Co., Ltd.	2
KeyFix Direct Access Needle	G21 SRL	2
Kyphoplasty Tool Kit	Jiangsu Changmei Medtech Co., Ltd.	2
Kiva	Benvenue Medical, Inc.	2
Vertebroplasty needles	Teknimed SAS	2
Aliquot	Stryker GmbH	2
Blazer	Benvenue Medical, Inc.	2

Showing 12 of 33. All products under Spinal Channeling Instrument, Vertebroplasty

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.