Array Spinal System
28 catalogue numbers from 94029, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Interlaminal. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
28catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| 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 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Record published | 2020-06-27 |
| Record revised | 2025-07-02 (version 6) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 94029 | 5.5MM DIA X 30MM PRE-BENT ROD ARRAY SPINAL SYSTEM | In distribution |
| 94355J | TI ALLOY 5.5MM DIA X 155MM ROD | In distribution |
| 94029J | 5.5MM DIA X 30MM PRE-BENT ROD WITH LINE | In distribution |
| 94045 | TI ALLOY 5.5MM DIA X 45MM ROD | In distribution |
| 94054J | 5.5MM DIA X 55MM PRE-BENT ROD | In distribution |
| 94416J | TI ALLOY 5.5MM DIA X 400MM ROD | In distribution |
| 94325J | TI ALLOY 5.5MM DIA X 125MM ROD | In distribution |
| 94315 | TI ALLOY 5.5MM DIA X 115MM ROD | In distribution |
| 94345J | TI ALLOY 5.5MM DIA X 145MM ROD | In distribution |
| 94090 | TI ALLOY 5.5MM DIA X 90MM ROD | In distribution |
| 94075J | TI ALLOY 5.5MM DIA X 75MM ROD | In distribution |
| 94085 | TI ALLOY 5.5MM DIA X 85MM ROD | In distribution |
| 94099J | 5.5MM DIA X 100MM PRE-BENT ROD | In distribution |
| 94090J | TI ALLOY 5.5MM DIA X 90MM ROD WITH LINE | In distribution |
| 94045J | TI ALLOY 5.5MM DIA X 45MM ROD WITH LINE | In distribution |
| 94418J | TI ALLOY 5.5MM DIA X 480MM ROD WITH LINE | In distribution |
| 94050J | TI ALLOY 5.5MM DIA X 50MM ROD | In distribution |
| 94070J | TI ALLOY 5.5MM DIA X 70MM ROD WITH LINE | In distribution |
| 94385J | TI ALLOY 5.5MM DIA X 185MM ROD | In distribution |
| 94315J | TI ALLOY 5.5MM DIA X 115MM ROD WITH LINE | In distribution |
| 94079 | 5.5MM DIA X 80MM PRE-BENT ROD ARRAY SPINAL SYSTEM | In distribution |
| 94355J | TI ALLOY 5.5MM DIA X 155MM ROD WITH LINE | In distribution |
| 94082 | 5.5MM DIA X 110MM ALLOY ROD ARRAY SPINAL SYSTEM | In distribution |
| 94069J | 5.5MM DIA X 70MM PRE-BENT ROD WITH LINE | In distribution |
| 94054J | 5.5MM DIA X 55MM PRE-BENT ROD WITH LINE | In distribution |
| 94089J | 5.5MM DIA X 90MM PRE-BENT ROD WITH LINE | In distribution |
| 94345J | TI ALLOY 5.5MM DIA X 145MM ROD WITH LINE | In distribution |
| 94064 | 5.5MM DIA X 65MM PRE-BENT ROD ARRAY SPINAL SYSTEM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K071377 | 2007-08-06 |
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.