White Pearl Preferred Angle ACP
White Pearl Preferred Angle ACP is a cervical plate-and-screw fixation family. Bone screws attach the plate to the anterior vertebral bodies, stabilizing the cervical spine while fusion…
White Pearl Preferred Angle ACP is a cervical plate-and-screw fixation family. Bone screws attach the plate to the anterior vertebral bodies, stabilizing the cervical spine while fusion develops.
The titanium alloy implant range includes plates, locking caps and bone screws. Fixed-angle and variable-angle screws are available with self-tapping or self-drilling designs, providing different screw configurations within the same system.
Listed Item
CERV SCREW, VARIABLE, SELF-DRILLING, 3.75x16mm, CORT/CANC, PREF ACP
Component and Fusion Role
A variable-angle self-drilling screw is one anchor component within the construct. The system serves cervical fixation from C2 through T1 in skeletally mature patients, and its plate is intended for removal after solid fusion.
14manufacturers in China registered for this device type
171catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Osseus Fusion Systems LLC, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K160522 |
| Record published | 2017-01-11 |
| Record revised | 2025-07-14 (version 5) |
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 8.5 to 105 mm; outer diameter 3.75 to 20 mm; width 17.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2100-6160 | In distribution | |
| 2100-0218 | Length 18 mm | In distribution |
| 2100-0120 | Outer Diameter 3.75 mm | In distribution |
| 2100-9612 | Outer Diameter 4.25 mm | In distribution |
| 2100-0110 | Length 10 mm | In distribution |
| 2100-0410 | Length 10 mm | In distribution |
| 2100-9718 | Length 18 mm | In distribution |
| 2100-9318 | Length 18 mm | In distribution |
| 2100-2140 | Width 17.5 mm | In distribution |
| 2100-6060 | In distribution | |
| 2100-3151 | Length 51 mm | In distribution |
| 2100-0712 | Outer Diameter 4.25 mm | In distribution |
| 2100-6020 | Outer Diameter 20 mm | In distribution |
| 2100-9410 | Length 10 mm | In distribution |
| 2100-0220 | Outer Diameter 3.75 mm | In distribution |
| 2100-9716 | Outer Diameter 4.25 mm | In distribution |
| 2100-2143 | Length 43 mm | In distribution |
| 2100-9116 | Outer Diameter 3.75 mm | In distribution |
| 2100-6016 | Outer Diameter 16 mm | In distribution |
| 2100-0810 | Length 10 mm | In distribution |
| 2100-0116 | Outer Diameter 3.75 mm | In distribution |
| 2100-0818 | Length 18 mm | In distribution |
| 2100-9114 | Length 14 mm | In distribution |
| 2100-0114 | Length 12 mm | In distribution |
| 2100-0520 | Outer Diameter 4.25 mm | In distribution |
| 2100-3139 | Length 39 mm | In distribution |
| 2100-6140 | In distribution | |
| 2100-0710 | Length 10 mm | In distribution |
| 2100-5190 | Width 17.5 mm | In distribution |
| 2100-0318 | Length 18 mm | In distribution |
| 2100-9120 | Outer Diameter 3.75 mm | In distribution |
| 2100-6210 | In distribution | |
| 2100-0720 | Outer Diameter 4.25 mm | In distribution |
| 2100-9816 | Outer Diameter 4.25 mm | In distribution |
| 2100-9618 | Length 18 mm | In distribution |
| 2100-0118 | Length 18 mm | In distribution |
| 2100-3145 | Length 45 mm | In distribution |
| 2100-6082 | In distribution | |
| 2100-2126 | Width 17.5 mm | In distribution |
| 2100-0812 | Outer Diameter 4.25 mm | In distribution |
| 2100-9214 | Length 14 mm | In distribution |
| 2100-9720 | Outer Diameter 4.25 mm | In distribution |
| 2100-9218 | Length 18 mm | In distribution |
| 2100-2122 | Length 22 mm | In distribution |
| 2100-0718 | Length 18 mm | In distribution |
| 2100-6200 | In distribution | |
| 2100-0614 | Length 14 mm | In distribution |
| 2100-0414 | Length 14 mm | In distribution |
| 2100-9414 | Length 14 mm | In distribution |
| 2100-0820 | Outer Diameter 4.25 mm | In distribution |
| 2100-9310 | Length 10 mm | In distribution |
| 2100-6220 | In distribution | |
| 2100-9220 | Outer Diameter 3.75 mm | In distribution |
| 2100-9316 | Outer Diameter 3.75 mm | In distribution |
| 2100-6110 | In distribution | |
| 2100-0620 | Outer Diameter 4.25 mm | In distribution |
| 2100-9110 | Length 10 mm | In distribution |
| 2100-6012 | Outer Diameter 12 mm | In distribution |
| 2100-3160 | Width 17.5 mm | In distribution |
| 2100-4160 | Width 17.5 mm | In distribution |
| 2100-3163 | Length 63 mm | In distribution |
| 2100-4180 | Length 80 mm | In distribution |
| 2100-0716 | Outer Diameter 4.25 mm | In distribution |
| 2100-0412 | Outer Diameter 3.75 mm | In distribution |
| 2100-6018 | Outer Diameter 18 mm | In distribution |
| 2100-9510 | Length 10 mm | In distribution |
| 2100-6090 | In distribution | |
| 2100-9312 | Outer Diameter 3.75 mm | In distribution |
| 2100-9514 | Length 14 mm | In distribution |
| 2100-0420 | Outer Diameter 3.75 mm | In distribution |
| 2100-1114 | Length 14 mm | In distribution |
| 2100-5105 | Width 17.5 mm | In distribution |
| 2100-0512 | Outer Diameter 4.25 mm | In distribution |
| 2100-6030 | In distribution | |
| 2100-0216 | Outer Diameter 3.75 mm | In distribution |
| 2100-0212 | Outer Diameter 3.75 mm | In distribution |
| 2100-0616 | Outer Diameter 4.25 mm | In distribution |
| 2100-6180 | In distribution | |
| 2100-5100 | Length 100 mm | In distribution |
| 2100-4172 | Length 72 mm | In distribution |
| 2100-9610 | Length 10 mm | In distribution |
| 2100-9516 | Outer Diameter 4.25 mm | In distribution |
| 2100-3169 | Length 69 mm | In distribution |
| 2100-0112 | Outer Diameter 3.75 mm | In distribution |
| 2100-3134 | Length 34 mm | In distribution |
| 2100-6080 | In distribution | |
| 2100-0316 | Outer Diameter 3.75 mm | In distribution |
| 2100-9412 | Outer Diameter 3.75 mm | In distribution |
| 2100-2130 | Width 17.5 mm | In distribution |
| 2100-9518 | Length 18 mm | In distribution |
| 2100-9216 | Outer Diameter 3.75 mm | In distribution |
| 2100-5185 | Length 85 mm | In distribution |
| 2100-6040 | In distribution | |
| 2100-4168 | Width 17.5 mm | In distribution |
| 2100-6050 | In distribution | |
| 2100-2134 | Width 17.5 mm | In distribution |
| 2100-3157 | Length 57 mm | In distribution |
| 2100-5195 | Length 95 mm | In distribution |
| 2100-9812 | Outer Diameter 4.25 mm | In distribution |
| 2100-9420 | Outer Diameter 3.75 mm | In distribution |
| 2100-3142 | Width 17.5 mm | In distribution |
| 2100-0418 | Length 18 mm | In distribution |
| 2100-9712 | Outer Diameter 4.25 mm | In distribution |
| 2100-0814 | Length 14 mm | In distribution |
| 2100-9416 | Outer Diameter 3.75 mm | In distribution |
| 2100-0510 | Length 10 mm | In distribution |
| 2100-3154 | Width 17.5 mm | In distribution |
| 2100-9520 | Outer Diameter 4.25 mm | In distribution |
| 2100-9112 | Outer Diameter 3.75 mm | In distribution |
| 2100-6170 | In distribution | |
| 2100-6190 | In distribution | |
| 2100-0210 | Length 10 mm | In distribution |
| 2100-6070 | In distribution | |
| 2100-6014 | Outer Diameter 14 mm | In distribution |
| 2100-9620 | Outer Diameter 4.25 mm | In distribution |
| 2100-9616 | Outer Diameter 4.25 mm | In distribution |
| 2100-2132 | Length 32 mm | In distribution |
| 2100-9810 | Length 10 mm | In distribution |
| 2100-0714 | Length 14 mm | In distribution |
| 2100-0516 | Outer Diameter 4.25 mm | In distribution |
| 2100-4184 | Width 17.5 mm | In distribution |
| 2100-0618 | Length 18 mm | In distribution |
| 2100-9512 | Outer Diameter 4.25 mm | In distribution |
| 2100-0816 | Outer Diameter 4.25 mm | In distribution |
| 2100-0610 | Length 10 mm | In distribution |
| 2100-2120 | Width 17.5 mm | In distribution |
| 2100-9210 | Length 10 mm | In distribution |
| 2100-1116 | Width 17.5 mm | In distribution |
| 2100-0612 | Outer Diameter 4.25 mm | In distribution |
| 2100-9320 | Outer Diameter 3.75 mm | In distribution |
| 2100-6100 | In distribution | |
| 2100-6120 | In distribution | |
| 2100-9614 | Length 14 mm | In distribution |
| 2100-1126 | Length 26 mm | In distribution |
| 2100-0416 | Outer Diameter 3.75 mm | In distribution |
| 2100-3136 | Width 17.5 mm | In distribution |
| 2100-0214 | Length 14 mm | In distribution |
| 2100-2137 | Length 37 mm | In distribution |
| 2100-0310 | Length 10 mm | In distribution |
| 2100-1118 | Length 18 mm | In distribution |
| 2100-0518 | Length 18 mm | In distribution |
| 2100-2146 | Width 17.5 mm | In distribution |
| 2100-5180 | Width 17.5 mm | In distribution |
| 2100-6010 | Outer Diameter 10 mm | In distribution |
| 2100-9820 | Outer Diameter 4.25 mm | In distribution |
| 2100-0320 | Outer Diameter 3.75 mm | In distribution |
| 2100-4176 | Width 17.5 mm | In distribution |
| 2100-3148 | Width 17.5 mm | In distribution |
| 2100-9118 | Length 18 mm | In distribution |
| 2100-0514 | Length 14 mm | In distribution |
| 2100-1112 | Width 17.5 mm | In distribution |
| 2100-9714 | Length 14 mm | In distribution |
| 2100-9314 | Length 14 mm | In distribution |
| 2100-0314 | Length 14 mm | In distribution |
| 2100-9212 | Outer Diameter 3.75 mm | In distribution |
| 2100-1124 | Width 17.5 mm | In distribution |
| 2100-9818 | Length 18 mm | In distribution |
| 2100-1122 | Length 22 mm | In distribution |
| 2100-5175 | Length 85 mm | In distribution |
| 2100-2128 | Length 28 mm | In distribution |
| 2100-1110 | Length 10 mm | In distribution |
| 2100-6150 | In distribution | |
| 2100-9418 | Length 18 mm | In distribution |
| 2100-9710 | Length 10 mm | In distribution |
| 2100-1108 | Width 17.5 mm | In distribution |
| 2100-2124 | Width 17.5 mm | In distribution |
| 2100-9814 | Length 14 mm | In distribution |
| 2100-1120 | Width 17.5 mm | In distribution |
| 2100-4164 | Length 64 mm | In distribution |
| 2100-0312 | Outer Diameter 3.75 mm | In distribution |
| 2100-3166 | Width 17.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160522 | 2016-04-26 |
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.