Orthopedic › ProstheticOrthosis, Spondylolisthesis Spinal Fixation

Sniper® Spine System

Cannulated Pedicle Screw Reduction Tab 10.5 mm x 120 mm

Registry build 21.09.26
13manufacturers in China registered for this device type
239catalogue numbers in this listing
3510(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 MNH
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, Spondylolisthesis Spinal Fixation

Record

Regulatory record for Sniper® Spine System
Listed by Spine Wave, Inc., United States
FDA product code MNH
Device type Orthosis, Spondylolisthesis Spinal Fixation
Device class Class 2
Regulation 21 CFR 888.3070
Establishment Specification developer, Repacker / relabeller, Manufacturer
510(k) K100605
Record published 2017-10-06
Record revised 2025-07-14 (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 Outer diameter 4.5 to 8.5 mm; length 15 to 500 mm

Catalogue Numbers

Catalogue numbers for Sniper® Spine System
Catalogue number Size Status
11-4331 In distribution
11-4445 Outer Diameter 4.5 mm In distribution
11-4205 In distribution
11-4451 Outer Diameter 4.5 mm In distribution
11-4604 Length 45 mm In distribution
11-4201 In distribution
11-4045 Outer Diameter 5.5 mm In distribution
11-4195 In distribution
11-4081 Outer Diameter 5.5 mm In distribution
11-4615 Outer Diameter 5.5 mm In distribution
11-4281 In distribution
11-4840 Length 40 mm In distribution
11-4760 Outer Diameter 7.5 mm In distribution
11-4196 In distribution
11-4202 In distribution
11-4282 In distribution
11-4227 In distribution
11-4325 In distribution
11-4336 In distribution
11-4204 In distribution
11-4334 In distribution
11-4184 In distribution
11-4556 Outer Diameter 5.5 mm In distribution
11-4599 Length 500 mm In distribution
11-4323 In distribution
11-4546 Outer Diameter 5.5 mm In distribution
11-4880 Outer Diameter 8.5 mm In distribution
11-4306 In distribution
11-4203 In distribution
11-4377 In distribution
11-4655 Length 55 mm In distribution
11-4055 Outer Diameter 5.5 mm In distribution
11-4292 In distribution
11-4112 Length 55 mm In distribution
11-4283 In distribution
11-4324 In distribution
11-4224 In distribution
11-4107 Outer Diameter 5.5 mm In distribution
11-4113 Outer Diameter 5.5 mm In distribution
10-4100.1 In distribution
11-4770 Length 70 mm In distribution
11-4182 In distribution
11-4296 In distribution
11-4650 Outer Diameter 6.5 mm In distribution
11-4114 Length 60 mm In distribution
11-4435 Outer Diameter 4.5 mm In distribution
11-4607 Length 60 mm In distribution
11-4185 In distribution
11-4376 In distribution
11-4289 In distribution
11-4221 In distribution
11-4226 In distribution
11-4363 In distribution
11-4228 In distribution
11-4555 Length 55 mm In distribution
11-4851 Outer Diameter 8.5 mm In distribution
11-4108 Length 30 mm In distribution
11-4099 Outer Diameter 5.5 mm In distribution
11-4602 Length 35 mm In distribution
11-4656 Outer Diameter 6.5 mm In distribution
11-4614 Outer Diameter 5.5 mm In distribution
11-4861 Outer Diameter 8.5 mm In distribution
11-4100 Outer Diameter 5.5 mm In distribution
11-4186 In distribution
11-4136 Length 105 mm In distribution
11-4436 Length 35 mm In distribution
11-4229 In distribution
11-4197 In distribution
11-4120 Outer Diameter 5.5 mm In distribution
11-4790 Length 90 mm In distribution
11-4260 Length 260 mm In distribution
11-4338 In distribution
11-4835 Outer Diameter 8.5 mm In distribution
11-4613 Outer Diameter 5.5 mm In distribution
11-4841 Outer Diameter 8.5 mm In distribution
11-4836 Length 35 mm In distribution
11-4098 Length 50 mm In distribution
11-4299 In distribution
11-4220 Length 220 mm In distribution
11-4855 Outer Diameter 8.5 mm In distribution
11-4373 In distribution
11-4103 Outer Diameter 5.5 mm In distribution
11-4755 Length 55 mm In distribution
11-4070 Length 70 mm In distribution
11-4756 Outer Diameter 7.5 mm In distribution
11-4375 In distribution
11-4740 Outer Diameter 7.5 mm In distribution
11-4371 In distribution
11-4140 Outer Diameter 5.5 mm In distribution
11-4456 Length 55 mm In distribution
11-4194 In distribution
11-4606 Outer Diameter 5.5 mm In distribution
11-4030 Length 30 mm In distribution
11-4285 In distribution
11-4183 In distribution
11-4635 Length 35 mm In distribution
11-4181 In distribution
11-4745 Length 45 mm In distribution
11-4295 In distribution
11-4364 In distribution
11-4431 Outer Diameter 4.5 mm In distribution
11-4609 Outer Diameter 5.5 mm In distribution
11-4850 Length 50 mm In distribution
11-4206 In distribution
11-4845 Outer Diameter 8.5 mm In distribution
11-4219 In distribution
11-4300 Length 300 mm In distribution
11-4630 Outer Diameter 6.5 mm In distribution
11-4579 Outer Diameter 5.5 mm In distribution
11-4422 Outer Diameter 4.5 mm In distribution
11-4322 In distribution
11-4450 Length 50 mm In distribution
11-4137 Length 115 mm In distribution
11-4092 Length 35 mm In distribution
11-4298 In distribution
11-4065 Outer Diameter 5.5 mm In distribution
11-4060 Length 60 mm In distribution
11-4530 Outer Diameter 5.5 mm In distribution
11-4160 Outer Diameter 5.5 mm In distribution
11-4616 Length 120 mm In distribution
11-4294 In distribution
11-4335 In distribution
11-4180 Outer Diameter 5.5 mm In distribution
11-4102 Length 15 mm In distribution
11-4200 Outer Diameter 5.5 mm In distribution
11-4293 In distribution
11-4426 Length 25 mm In distribution
11-4170 Length 170 mm In distribution
11-4332 In distribution
11-4361 In distribution
11-4735 Length 35 mm In distribution
11-4109 Outer Diameter 5.5 mm In distribution
11-4603 Length 40 mm In distribution
11-4535 Length 35 mm In distribution
11-4213 In distribution
11-4430 Length 30 mm In distribution
11-4420 Length 20 mm In distribution
11-4339 In distribution
10-4153 In distribution
11-4440 Length 40 mm In distribution
11-4222 In distribution
11-4225 In distribution
11-4215 In distribution
11-4110 Length 110 mm In distribution
11-4280 Outer Diameter 5.5 mm In distribution
11-4095 Outer Diameter 5.5 mm In distribution
11-4090 Length 90 mm In distribution
11-4106 Length 25 mm In distribution
11-4640 Outer Diameter 6.5 mm In distribution
11-4856 Length 55 mm In distribution
11-4050 Length 50 mm In distribution
10-4104 In distribution
11-4187 In distribution
11-4830 Outer Diameter 8.5 mm In distribution
11-4368 In distribution
11-4150 Length 150 mm In distribution
11-4085 Outer Diameter 5.5 mm In distribution
11-4198 In distribution
11-4287 In distribution
11-4605 Outer Diameter 5.5 mm In distribution
11-4446 Length 45 mm In distribution
11-4105 Outer Diameter 5.5 mm In distribution
11-4071 Length 70 mm In distribution
11-4525 Length 25 mm In distribution
11-4093 Outer Diameter 5.5 mm In distribution
11-4337 In distribution
11-4288 In distribution
11-4327 In distribution
11-4330 In distribution
11-4870 Length 70 mm In distribution
11-4750 Outer Diameter 7.5 mm In distribution
11-4097 Outer Diameter 5.5 mm In distribution
11-4362 In distribution
11-4297 In distribution
11-4286 In distribution
11-4212 In distribution
11-4646 Outer Diameter 6.5 mm In distribution
11-4378 In distribution
11-4091 Length 90 mm In distribution
11-4645 Length 45 mm In distribution
11-4211 In distribution
11-4080 Length 80 mm In distribution
11-4365 In distribution
11-4369 In distribution
11-4526 Outer Diameter 5.5 mm In distribution
11-4536 Outer Diameter 5.5 mm In distribution
11-4372 In distribution
11-4730 Outer Diameter 7.5 mm In distribution
11-4736 Outer Diameter 7.5 mm In distribution
11-4780 Outer Diameter 7.5 mm In distribution
11-4111 Length 110 mm In distribution
11-4121 Outer Diameter 5.5 mm In distribution
11-4545 Length 45 mm In distribution
11-4442 Outer Diameter 4.5 mm In distribution
11-4075 Outer Diameter 5.5 mm In distribution
11-4284 In distribution
11-4831 Length 30 mm In distribution
11-4860 Length 60 mm In distribution
11-4611 Length 80 mm In distribution
11-4241 Outer Diameter 5.5 mm In distribution
11-4214 In distribution
11-4321 In distribution
11-4188 In distribution
11-4326 In distribution
11-4374 In distribution
11-4190 Length 190 mm In distribution
11-4540 Outer Diameter 5.5 mm In distribution
11-4217 In distribution
11-4096 Length 45 mm In distribution
11-4291 In distribution
11-4094 Length 40 mm In distribution
11-4135 Outer Diameter 5.5 mm In distribution
11-4001 In distribution
11-4329 In distribution
11-4890 Length 90 mm In distribution
11-4746 Outer Diameter 7.5 mm In distribution
11-4232 In distribution
11-4104 Length 20 mm In distribution
11-4367 In distribution
10-4037 In distribution
11-4192 In distribution
11-4328 In distribution
11-4130 Length 130 mm In distribution
11-4425 Outer Diameter 4.5 mm In distribution
11-4550 Outer Diameter 5.5 mm In distribution
10-4100.2 In distribution
11-4455 Outer Diameter 4.5 mm In distribution
11-4846 Length 45 mm In distribution
11-4040 Length 40 mm In distribution
11-4035 Outer Diameter 5.5 mm In distribution
11-4223 In distribution
11-4193 In distribution
11-4370 In distribution
11-4101 Outer Diameter 5.5 mm In distribution
11-4216 In distribution
11-4636 Outer Diameter 6.5 mm In distribution
11-4366 In distribution
11-4333 In distribution
11-4218 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
CD Horizon® Spinal System Medtronic Sofamor Danek, Inc. 3,144
Anax™ 5.5 Spinal System CG MedTech Co., Ltd. 2,177
ReLine Nuvasive, Inc. 2,010
Creo Globus Medical, Inc. 1,619
Perfix™ Spinal System CG MedTech Co., Ltd. 1,476
Apex Spine System Spinecraft LLC 1,193
Olympic Astura Medical 1,173
Arsenal Alphatec Spine, Inc. 1,001
Revere Globus Medical, Inc. 997
Astra Spine System Spinecraft LLC 798
Apex-DL Spine System Spinecraft LLC 735
Zenius Spinal System Medyssey Co., Ltd. 712

Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K132403 2014-01-10
K100605 2010-06-04
K100122 2010-02-12

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