Who else makes this device?

Name: High V+ Spinal Cement System
Brand: High V+ Spinal Cement System

Orthopedic › ProstheticCement, Bone, Vertebroplasty

High V+ Spinal Cement System

Catalogue number T040321K, listed by Teknimed SAS, France, under Cement, Bone, Vertebroplasty. 5 manufacturers in China are registered for this product code.

Registry build 21.09.26

5manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

1recall

Who Else Makes It

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

Chinese manufacturers registered for FDA product code NDN
Manufacturer	City	Province	Registered as	Device types
Medtronic (Changzhou) Medical Devices Technology Co., Ltd.	Changzhou	Jiangsu	Manufacturer	53
Shanghai KiNETIC Medical Co Ltd	Shanghai	Shanghai	Contract manufacturer	19
Ningbo Hicren Biotechnology Co., Ltd.	Ningbo	Zhejiang	Manufacturer	5
Jieno Youcheng Medical Technology (Shanghai) Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	3
Dragon Crown Medical Co., Ltd.	Jinan	Shandong	Manufacturer	2

Record

Regulatory record for High V+ Spinal Cement System
Listed by	Teknimed SAS, France
FDA product code	NDN
Device type	Cement, Bone, Vertebroplasty
Device class	Class 2
Regulation	21 CFR 888.3027
Establishment	Complaint-file establishment, Manufacturer
Record published	2017-08-22
Record revised	2018-03-29 (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	Storage environment temperature up to 25 °C

Catalogue Numbers

Catalogue numbers for High V+ Spinal Cement System
Catalogue number	Size	Status
T040321K		In distribution

Same Product Code

Other products under the same FDA product code
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Zavation	Zavation	284
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StabiliT®	Merit Medical Systems, Inc.	42
Medinaut Plus Kyphoplasty System	Imedicom Co., Ltd.	41
iVAS	Stryker GmbH	35
V-Strut Vertebral Implant	Hyprevention	28
Tracker Plus Kyphoplasty System	GS Medical Co., Ltd.	25
StabiliT MX Fracture Kit	Dfine, Inc.	12
Osseoflex®	Merit Medical Systems, Inc.	8
Synth™ BES	Imedicom Co., Ltd.	8
Tracker	GS Medical Co., Ltd.	6
AVAflex	Stryker GmbH	6

Showing 12 of 210. All products under Cement, Bone, Vertebroplasty

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K161114	2017-04-12
K103816	2011-02-04

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of High V+ Spinal Cement System
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Teknimed SAS	UDI-DI	2022-12-15	Class II	Employee error	Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28.	236 systems

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.