Ozark Cervical Plate System
Self-Starting, Variable Screw, Size Ø4.35x26 mm
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 | VB Spine LLC |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Record published | 2018-12-12 |
| Record revised | 2026-04-20 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 10 to 110 mm; outer diameter 4 to 4.5 mm |
| Distribution end date | 2026-01-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8801-43F66G-G1 | Length 66 mm | In distribution |
| 8801-14526DA | Length 26 mm | In distribution |
| 8801-14310DA-G1 | Length 10 mm | In distribution |
| 8801-04014DA-G1 | Length 14 mm | In distribution |
| AA01-41F18V-G1 | Length 18 mm | In distribution |
| AA01-43F58V-G1 | Length 58 mm | In distribution |
| AA01-43F50V-G1 | Length 50 mm | In distribution |
| 8801-14311CA | Length 11 mm | In distribution |
| AA01-42F53V-G1 | Length 53 mm | In distribution |
| AA01-44F90V-G1 | 4 Level | In distribution |
| 8801-04523DA-G1 | Length 23 mm | In distribution |
| 8801-04321DA-G1 | Outer Diameter 4.35 mm | In distribution |
| 8801-44F84G | Length 84 mm | In distribution |
| AA01-41F24V | Length 24 mm | In distribution |
| 8801-14020DA-G1 | Length 20 mm | In distribution |
| 8801-45F96G-G1 | Length 96 mm | In distribution |
| AA01-44F92V-G1 | 4 Level | In distribution |
| 8801-04311CA | Outer Diameter 4.35 mm | In distribution |
| 8801-44F88G | Length 88 mm | In distribution |
| 8801-14324CA | Outer Diameter 4.35 mm | In distribution |
| 8801-42F43G-G1 | 2 Level | In distribution |
| AA01-42F49V-G1 | Length 49 mm | In distribution |
| 8801-04515CA-G1 | Outer Diameter 4.5 mm | In distribution |
| 8801-43F73G-G1 | 3 Level | In distribution |
| 8801-14021CA-G1 | Outer Diameter 4 mm | In distribution |
| 8801-44F62G | Length 62 mm | In distribution |
| 8801-42F36G-G1 | Length 36 mm | In distribution |
| 8801-14515CA-G1 | Outer Diameter 4.5 mm | In distribution |
| 8801-44F86G-G1 | Length 86 mm | In distribution |
| 8801-44F66G | Length 66 mm | In distribution |
| 8801-04325CA | Length 25 mm | In distribution |
| 8801-42F39G | Length 39 mm | In distribution |
| 8801-44F60G | Length 60 mm | In distribution |
| 8801-04521DA | Length 21 mm | In distribution |
| 8801-44F77G | Length 77 mm | In distribution |
| AA01-41F26V-G1 | Length 26 mm | In distribution |
| 8801-44F71G-G1 | Length 71 mm | In distribution |
| 8801-42F42G | Length 42 mm | In distribution |
| 8801-14316CA | Length 16 mm | In distribution |
| 8801-43F57G | Length 57 mm | In distribution |
| 8801-14023CA | Length 23 mm | In distribution |
| 8801-04010CA | Outer Diameter 4 mm | In distribution |
| 8801-41F36G | Length 36 mm | In distribution |
| AA01-42F33V-G1 | 2 Level | In distribution |
| 8801-04521CA | Length 21 mm | In distribution |
| 8801-41F16G-G1 | Length 16 mm | In distribution |
| 8801-04310CA | Outer Diameter 4.35 mm | In distribution |
| AA01-42F52V | Length 52 mm | In distribution |
| 8801-04311CA-G1 | Length 11 mm | In distribution |
| 8801-04512CA-G1 | Outer Diameter 4.5 mm | In distribution |
| 8801-44F96G | Length 96 mm | In distribution |
| 8801-42F56G | Length 56 mm | In distribution |
| 8801-14018DA | Outer Diameter 4 mm | In distribution |
| 8801-04522CA | Length 22 mm | In distribution |
| AA01-41F32V-G1 | Length 32 mm | In distribution |
| AA01-41F20V | Length 20 mm | In distribution |
| 8801-44F66G-G1 | Length 66 mm | In distribution |
| 8801-44F69G | Length 69 mm | In distribution |
| AA01-41F21V-G1 | Length 21 mm | In distribution |
| AA01-43F76V-G1 | 3 Level | In distribution |
| AA01-42F36V | Length 36 mm | In distribution |
| AA01-43F67V-G1 | Length 67 mm | In distribution |
| 8801-14321DA | Length 21 mm | In distribution |
| 8801-45F98G-G1 | 5 Level | In distribution |
| 8801-43F70G-G1 | Length 70 mm | In distribution |
| 8801-44F98G | Length 98 mm | In distribution |
| 8801-45F90G | Length 90 mm | In distribution |
| AA01-42F32V | Length 32 mm | In distribution |
| 8801-04019CA | Outer Diameter 4 mm | In distribution |
| 8801-43F37G-G1 | Length 37 mm | In distribution |
| 8801-04026DA | Outer Diameter 4 mm | In distribution |
| AA01-44F78V-G1 | 4 Level | In distribution |
| 8801-14518CA-G1 | Length 18 mm | In distribution |
| 8801-41F20G-G1 | 1 Level | In distribution |
| 8801-04515DA | Length 15 mm | In distribution |
| 8801-44F65G | Length 65 mm | In distribution |
| 8801-42F50G | Length 50 mm | In distribution |
| 8801-45F91G-G1 | Length 91 mm | In distribution |
| AA01-44F69V-G1 | Length 69 mm | In distribution |
| 8801-42F32G | Length 32 mm | In distribution |
| 8801-41F16G | Length 16 mm | In distribution |
| 8801-43F54G-G1 | Length 54 mm | In distribution |
| AA01-41F17V-G1 | Length 17 mm | In distribution |
| 8801-14010CA-G1 | Outer Diameter 4 mm | In distribution |
| AA01-41F30V-G1 | Length 30 mm | In distribution |
| 8801-14025DA | Length 25 mm | In distribution |
| 8801-04311DA-G1 | Outer Diameter 4.35 mm | In distribution |
| 8801-41F23G-G1 | 1 Level | In distribution |
| 8801-43F78G-G1 | 3 Level | In distribution |
| 8801-14022DA-G1 | Length 22 mm | In distribution |
| 8801-14022DA | Outer Diameter 4 mm | In distribution |
| 8801-04014DA | Outer Diameter 4 mm | In distribution |
| AA01-44F70V-G1 | 4 Level | In distribution |
| AA01-45F105V-G1 | 5 Level | In distribution |
| 8801-43F44G-G1 | 3 Level | In distribution |
| 8801-14017CA | Length 17 mm | In distribution |
| AA01-44F73V-G1 | Length 73 mm | In distribution |
| 8801-14016CA | Outer Diameter 4 mm | In distribution |
| 8801-44F52G | Length 52 mm | In distribution |
| AA01-42F43V-G1 | Length 43 mm | In distribution |
| 8801-14317DA | Outer Diameter 4.35 mm | In distribution |
| 8801-43F71G | Length 71 mm | In distribution |
| 8801-04017CA-G1 | Length 17 mm | In distribution |
| 8801-04310DA | Length 10 mm | In distribution |
| 8801-43F64G | Length 64 mm | In distribution |
| 8801-04015CA | Length 15 mm | In distribution |
| 8801-42F50G-G1 | Length 50 mm | In distribution |
| 8801-14320DA | Outer Diameter 4.35 mm | In distribution |
| 8801-14013DA-G1 | Length 13 mm | In distribution |
| 8801-04512DA-G1 | Length 12 mm | In distribution |
| 8801-42F44G-G1 | Length 44 mm | In distribution |
| AA01-43F52V-G1 | Length 52 mm | In distribution |
| 8801-04026DA-G1 | Length 26 mm | In distribution |
| 8801-14518DA-G1 | Length 18 mm | In distribution |
| AA01-44F84V-G1 | Length 84 mm | In distribution |
| 8801-43F72G-G1 | 3 Level | In distribution |
| 8801-14524DA-G1 | Outer Diameter 4.5 mm | In distribution |
| 8801-41F25G-G1 | 1 Level | In distribution |
| AA01-42F46V-G1 | Length 46 mm | In distribution |
| 8801-14519DA | Length 19 mm | In distribution |
| 8801-04320DA-G1 | Length 20 mm | In distribution |
| 8801-04319DA | Outer Diameter 4.35 mm | In distribution |
| 8801-04323DA | Length 23 mm | In distribution |
| 8801-04010DA | Outer Diameter 4 mm | In distribution |
| AA01-44F97V | Length 97 mm | In distribution |
| AA01-44F96V-G1 | Length 96 mm | In distribution |
| 8801-14515DA-G1 | Length 15 mm | In distribution |
| AA01-43F54V | Length 54 mm | In distribution |
| 8801-42F49G | Length 49 mm | In distribution |
| 8801-04526CA | Outer Diameter 4.5 mm | In distribution |
| 8801-04025DA-G1 | Outer Diameter 4 mm | In distribution |
| AA01-45F96V-G1 | 5 Level | In distribution |
| 8801-43F39G-G1 | Length 39 mm | In distribution |
| 8801-44F73G-G1 | 4 Level | In distribution |
| 8801-43F53G-G1 | Length 53 mm | In distribution |
| 8801-04022CA | Outer Diameter 4 mm | In distribution |
| 8801-14511DA | Length 11 mm | In distribution |
| 8801-44F100G-G1 | Length 100 mm | In distribution |
| 8801-43F76G-G1 | Length 76 mm | In distribution |
| 8801-41F19G | Length 19 mm | In distribution |
| AA01-44F69V | Length 69 mm | In distribution |
| 8801-04525CA | Outer Diameter 4.5 mm | In distribution |
| 8801-04015DA | Length 15 mm | In distribution |
| 8801-14310DA | Outer Diameter 4.35 mm | In distribution |
| 8801-04524DA-G1 | Outer Diameter 4.5 mm | In distribution |
| AA01-42F39V-G1 | 2 Level | In distribution |
| 8801-14526DA-G1 | Outer Diameter 4.5 mm | In distribution |
| AA01-45F99V-G1 | 5 Level | In distribution |
| 8801-04314DA-G1 | Length 14 mm | In distribution |
| 8801-04316DA-G1 | Outer Diameter 4.35 mm | In distribution |
| 8801-43F75G | Length 75 mm | In distribution |
| AA01-44F93V | Length 93 mm | In distribution |
| 8801-04018CA | Outer Diameter 4 mm | In distribution |
| 8801-04517DA-G1 | Outer Diameter 4.5 mm | In distribution |
| 8801-41F29G-G1 | 1 Level | In distribution |
| 8801-42F47G-G1 | 2 Level | In distribution |
| 8801-42F51G | Length 51 mm | In distribution |
| 8801-04312DA | Length 12 mm | In distribution |
| 8801-41F35G-G1 | Length 35 mm | In distribution |
| 8801-44F62G-G1 | Length 62 mm | In distribution |
| 8801-43F66G | Length 66 mm | In distribution |
| 8801-44F54G-G1 | 4 Level | In distribution |
| 8801-04020DA | Length 20 mm | In distribution |
| 8801-43F70G | Length 70 mm | In distribution |
| 8801-44F82G-G1 | 4 Level | In distribution |
| 8801-44F75G-G1 | Length 75 mm | In distribution |
| 8801-14517CA-G1 | Outer Diameter 4.5 mm | In distribution |
| 8801-14314CA-G1 | Length 14 mm | In distribution |
| AA01-42F36V-G1 | Length 36 mm | In distribution |
| 8801-14310CA | Length 10 mm | In distribution |
| 8801-41F36G-G1 | 1 Level | In distribution |
| AA01-44F81V-G1 | 4 Level | In distribution |
| 8801-04516DA | Outer Diameter 4.5 mm | In distribution |
| 8801-44F60G-G1 | Length 60 mm | In distribution |
| 8801-04012DA-G1 | Outer Diameter 4 mm | In distribution |
| 8801-04015CA-G1 | Length 15 mm | In distribution |
| 8801-41F17G | Length 17 mm | In distribution |
| 8801-14322DA | Outer Diameter 4.35 mm | In distribution |
| 8801-14017DA-G1 | Outer Diameter 4 mm | In distribution |
| 8801-41F34G | Length 34 mm | In distribution |
| AA01-43F68V-G1 | Length 68 mm | In distribution |
| 8801-45F109G | Length 109 mm | In distribution |
| 8801-04017DA | Length 17 mm | In distribution |
| 8801-04019DA | Length 19 mm | In distribution |
| 8801-42F33G | Length 33 mm | In distribution |
| 8801-14020CA | Outer Diameter 4 mm | In distribution |
| 8801-14025CA-G1 | Length 25 mm | In distribution |
| 8801-43F62G-G1 | Length 62 mm | In distribution |
| AA01-42F32V-G1 | Length 32 mm | In distribution |
| 8801-44F74G-G1 | Length 74 mm | In distribution |
| 8801-04018DA-G1 | Length 18 mm | In distribution |
| 8801-14516DA-G1 | Length 16 mm | In distribution |
| 8801-44F80G-G1 | Length 80 mm | In distribution |
| 8801-45F107G | Length 107 mm | In distribution |
| 8801-04023DA | Outer Diameter 4 mm | In distribution |
| 8801-14019CA-G1 | Length 19 mm | In distribution |
| 8801-14523DA-G1 | Outer Diameter 4.5 mm | In distribution |
| AA01-42F54V | Length 54 mm | In distribution |
| 8801-04510CA-G1 | Length 10 mm | In distribution |
| AA01-45F100V | Length 100 mm | In distribution |
| 8801-43F64G-G1 | Length 64 mm | In distribution |
| 8801-42F46G | Length 46 mm | In distribution |
| 8801-14021DA-G1 | Length 21 mm | In distribution |
| AA01-42F46V | Length 46 mm | In distribution |
| 8801-04319CA-G1 | Outer Diameter 4.35 mm | In distribution |
| AA01-44F91V-G1 | Length 91 mm | In distribution |
| 8801-14322DA-G1 | Length 22 mm | In distribution |
| 8801-04019CA-G1 | Length 19 mm | In distribution |
| AA01-42F34V | Length 34 mm | In distribution |
| 8801-43F47G | Length 47 mm | In distribution |
| AA01-43F72V-G1 | Length 72 mm | In distribution |
| 8801-14313CA | Length 13 mm | In distribution |
| 8801-44F57G | Length 57 mm | In distribution |
| 8801-45F108G-G1 | Length 108 mm | In distribution |
| AA01-43F77V-G1 | Length 77 mm | In distribution |
| AA01-41F32V | Length 32 mm | In distribution |
| 8801-45F105G | Length 105 mm | In distribution |
| 8801-44F96G-G1 | 4 Level | In distribution |
| 8801-14014DA | Length 14 mm | In distribution |
| 8801-04317CA-G1 | Outer Diameter 4.35 mm | In distribution |
| 8801-14515CA | Length 15 mm | In distribution |
| 8801-42F51G-G1 | 2 Level | In distribution |
| AA01-41F28V | Length 28 mm | In distribution |
| 8801-04514DA | Length 14 mm | In distribution |
| 8801-44F70G | Length 70 mm | In distribution |
| 8801-44F89G-G1 | Length 89 mm | In distribution |
| 8801-44F59G | Length 59 mm | In distribution |
| 8801-04520CA | Outer Diameter 4.5 mm | In distribution |
| 8801-14525CA | Length 25 mm | In distribution |
| 8801-42F31G-G1 | Length 31 mm | In distribution |
| 8801-44F90G | Length 90 mm | In distribution |
| AA01-44F63V-G1 | Length 63 mm | In distribution |
| AA01-44F89V | Length 89 mm | In distribution |
| 8801-14521CA-G1 | Length 21 mm | In distribution |
| AA01-42F45V-G1 | 2 Level | In distribution |
| AA01-44F85V | Length 85 mm | In distribution |
| 8801-44F83G-G1 | Length 83 mm | In distribution |
| 8801-44F71G | Length 71 mm | In distribution |
| AA01-42F51V-G1 | 2 Level | In distribution |
| 8801-14522DA-G1 | Length 22 mm | In distribution |
| 8801-04516CA | Outer Diameter 4.5 mm | In distribution |
| AA01-43F60V-G1 | 3 Level | In distribution |
| 8801-04524DA | Outer Diameter 4.5 mm | In distribution |
| 8801-45F96G | Length 96 mm | In distribution |
| AA01-43F59V-G1 | 3 Level | In distribution |
| 8801-14317CA-G1 | Outer Diameter 4.35 mm | In distribution |
| 8801-44F98G-G1 | Length 98 mm | In distribution |
| 8801-14510DA-G1 | Outer Diameter 4.5 mm | In distribution |
| 8801-44F52G-G1 | Length 52 mm | In distribution |
| 8801-41F33G | Length 33 mm | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| CastleLoc-P Anterior Cervical Plate System | L&K Biomed Co., Ltd. | 873 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
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.