Orthopedic › ProstheticOrthosis, Spinal Pedicle Fixation

CapSure® Spine System

Rod Hex End Straight CoCr 5.5mm X 400mm

Registry build 21.09.26
13manufacturers in China registered for this device type
83catalogue numbers in this listing
11510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MNI
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
APS Materials Suzhou Suzhou Jiangsu Contract manufacturer 18
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Johnson & Johnson Medical (Depuy – Suzhou) Ltd. Suzhou Jiangsu Manufacturer 34
Double Medical Technology Inc. Xiamen Fujian Contract manufacturer 14
Suzhou Kangli Orthopaedics Instrument Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 11
Changzhou Yonghua Medical Instruments Co., Ltd. Changzhou Jiangsu Manufacturer 8
Jiangsu Ideal Medical Science & Technology Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 7

Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spinal Pedicle Fixation

Record

Regulatory record for CapSure® Spine System
Listed by Spine Wave, Inc., United States
FDA product code MNI
Device type Orthosis, Spinal Pedicle Fixation
Device class Class 2
Regulation 21 CFR 888.3070
Establishment Specification developer, Repacker / relabeller, Manufacturer
510(k) K070245
Record published 2015-10-24
Record revised 2024-09-11 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number
Sizes Length 20 to 500 mm; outer diameter 4.5 to 10.5 mm
Distribution end date 2020-04-17

Catalogue Numbers

Catalogue numbers for CapSure® Spine System
Catalogue number Size Status
11-3166 Length 40 mm In distribution
11-3085 Length 85 mm In distribution
11-3075 Length 75 mm In distribution
11-3250 Length 50 mm In distribution
11-3935 Length 35 mm In distribution
11-3851 Length 50 mm In distribution
11-3970 Length 70 mm In distribution
11-3184 Length 500 mm In distribution
11-3552 Length 50 mm In distribution
11-3164 Length 20 mm In distribution
11-3364 Length 100 mm In distribution
11-3847 Length 45 mm In distribution
11-3240 Length 40 mm In distribution
11-3831 Length 30 mm In distribution
11-3178 Length 200 mm In distribution
11-3810 Length 100 mm In distribution
11-3990 Length 90 mm In distribution
11-3841 Length 40 mm In distribution
11-3211 Length 110 mm In distribution
11-3732 Length 30 mm In distribution
11-3213 Length 130 mm In distribution
11-3260 Length 60 mm In distribution
11-3280 Length 80 mm In distribution
11-3055 Length 55 mm In distribution
11-3542 Length 40 mm In distribution
11-3440 Length 40 mm In distribution
11-3160 In distribution
11-3426 Length 25 mm In distribution
11-3270 Length 70 mm In distribution
11-3456 Length 55 mm In distribution
11-3955 Length 55 mm In distribution
11-3446 Length 45 mm In distribution
11-3642 Length 40 mm In distribution
11-3366 Length 120 mm In distribution
11-3632 Length 30 mm In distribution
11-3532 Length 30 mm In distribution
11-3157 In distribution
11-3350 Length 30 mm In distribution
11-3035 Length 35 mm In distribution
11-3752 Length 50 mm In distribution
11-3154 Length 30 mm In distribution
11-3880 Length 80 mm In distribution
11-3352 Length 40 mm In distribution
11-3812 Length 120 mm In distribution
11-3230 Length 30 mm In distribution
11-3301 Length 300 mm In distribution
11-3354 Length 50 mm In distribution
11-3120 Length 120 mm In distribution
11-3020 Small In distribution
11-3100 Length 100 mm In distribution
11-3065 Length 65 mm In distribution
11-3186 In distribution
11-3360 Length 80 mm In distribution
11-3861 Length 60 mm In distribution
11-3436 Length 35 mm In distribution
11-3046 Length 45 mm In distribution
11-3712 Length 120 mm In distribution
11-3780 Length 80 mm In distribution
11-3910 Length 100 mm In distribution
11-3356 Length 60 mm In distribution
11-3022 Large In distribution
11-3945 Length 45 mm In distribution
11-3837 Length 35 mm In distribution
11-3173 Length 400 mm In distribution
11-3912 Length 120 mm In distribution
11-3430 Length 30 mm In distribution
11-3420 Length 20 mm In distribution
11-3742 Length 40 mm In distribution
11-3290 Length 90 mm In distribution
11-3857 Length 55 mm In distribution
11-3762 Length 60 mm In distribution
11-3652 Length 50 mm In distribution
11-3710 Length 100 mm In distribution
11-3736 Length 35 mm Withdrawn
11-3556 Length 55 mm Withdrawn
11-3526 Length 25 mm Withdrawn
11-3536 Length 35 mm Withdrawn
11-3546 Length 45 mm Withdrawn
11-3756 Length 55 mm Withdrawn
11-3646 Length 45 mm Withdrawn
11-3656 Length 55 mm Withdrawn
11-3636 Length 35 mm Withdrawn
11-3746 Length 45 mm Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
CD Horizon® Spinal System Medtronic Sofamor Danek, Inc. 2,342
Creo Globus Medical, Inc. 1,784
ReLine Nuvasive, Inc. 1,718
AnyPlus Spinal Fixation System GS Medical Co., Ltd. 1,525
Apex Spine System Spinecraft LLC 1,114
Revere Globus Medical, Inc. 1,051
LnK Spinal Fixation System L&K Biomed Co., Ltd. 974
LnK Basic Spinal Fixation System L&K Biomed Co., Ltd. 935
Arsenal Alphatec Spine, Inc. 932
Zavation Zavation 864
Polaris™ 5.5 Spinal System Biomet Spine 809
Apex-DL Spine System Spinecraft LLC 792

Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K160003 2016-02-26
K152174 2015-08-31
K151813 2015-07-31
K132154 2013-08-09
K122233 2012-10-11
K120646 2012-06-07
K111913 2011-08-31
K083743 2009-01-13
K083353 2008-12-11
K081228 2008-05-12
K070245 2007-04-05

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer