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.

Kiva · Spinal Channeling Instrument, Vertebroplasty → Orthopedic

Name: Kiva
Brand: Kiva

5manufacturers in China registered for this device type

2catalogue numbers in this listing

1510(k) clearance

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 Kiva
Listed by	Benvenue Medical, Inc., United States
FDA product code	OCJ
Device type	Spinal Channeling Instrument, Vertebroplasty
Device class	Class 1
Regulation	21 CFR 888.4540
510(k)	K070293
Record published	2016-09-24
Record revised	2018-07-06 (version 3)

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
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Kiva
Catalogue number	Size	Status
PLT1910		In distribution
PLT1900		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
Vertebroplasty needles	Teknimed SAS	2
Aliquot	Stryker GmbH	2
Blazer	Benvenue Medical, Inc.	2
Main-AXS Needle-Spinal Simplicity	Mainstream Medical Devices	2

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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K070293	2007-07-10

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.

Kiva