Who else makes this device?

Name: Polyaxial Screw, 5.5
Brand: Polyaxial Screw, 5.5

Polyaxial Screw, 5.5 · Orthosis, Spinal Pedicle Fixation → Orthopedic

13manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

1recall

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 Polyaxial Screw, 5.5
Listed by	Captiva Spine, 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, Complaint-file establishment, Manufacturer
510(k)	K120292
Record published	2015-10-30
Record revised	2025-07-02 (version 4)

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
Distribution end date	2017-07-28

Catalogue Numbers

Catalogue numbers for Polyaxial Screw, 5.5
Catalogue number	Size	Status
2412-5545		Withdrawn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
K122332	2012-10-16
K120292	2012-04-13
K111115	2011-09-13

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Polyaxial Screw, 5.5
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Captiva Spine, Inc.	510(k) number	2012-09-20	Class II	Nonconforming Material/Component	Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking	10	2013-01-11

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.

Polyaxial Screw, 5.5