Who else makes this device?

Name: Cytoplast™ Osteo-Mesh TM-300
Brand: Cytoplast™ Osteo-Mesh TM-300

Cytoplast™ Osteo-Mesh TM-300 · Plate, Bone → Dental

3manufacturers in China registered for this device type

2catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (1), Shanghai (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JEY
Manufacturer	City	Province	Registered as	Device types
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	54
LX Precision Shanghai Co Ltd	Shanghai	Shanghai	Contract manufacturer	19
Kontour (Xi’an) Medical Technology Co., Ltd.	Xi’An	Shaanxi	Contract manufacturer	4

Record

Regulatory record for Cytoplast™ Osteo-Mesh TM-300
Listed by	Osteogenics Biomedical, Inc., United States
FDA product code	JEY
Device type	Plate, Bone
Device class	Class 2
Regulation	21 CFR 872.4760
Establishment	Contract manufacturer, Repacker / relabeller, Manufacturer
Record published	2016-05-03
Record revised	2023-10-04 (version 7)

Specifications

Specifications
MRI safety	MR Conditional
Sterilisation	Moist Heat or Steam Sterilization
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date
Sizes	Length 34 to 45 mm; width 25 to 45 mm

Catalogue Numbers

Catalogue numbers for Cytoplast™ Osteo-Mesh TM-300
Catalogue number	Size	Status
TM2534NS	Length 34 mm	In distribution
TM4545NS	Length 45 mm	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Plate, Bone	Stryker Leibinger Gmbh & Co. KG	1,338
Level ONE CMF	KLS-Martin L.P.	1,160
Medicon	Medicon eG. Chirurgiemechaniker-Genossenschaft	843
OsteoMed	Osteomed	675
Bioplate®	Bioplate, Inc.	669
Plate, Bone	Synthes Gmbh	568
Leforte System Bone Plate	Jeil Medical Corporation	466
CMF Visionare	Visionare LLC	421
Level ONE CMF, Sterile	KLS-Martin L.P.	416
Faico CMF System	Faico Medical, LLC	361
TraumaOne System	Biomet Microfixation	357
MatrixMANDIBLE	Synthes Gmbh	277

Showing 12 of 152. All products under Plate, Bone

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K984230	1999-02-04

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.

Cytoplast™ Osteo-Mesh TM-300