Altius OCT Post. Spine SYS.
89 catalogue numbers from 1200-3145, 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
89catalogue 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 | 2015-10-24 |
| 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 |
|---|---|---|
| 1200-3145 | 45 – 55MM | In distribution |
| 1200-1724 | 4.75MM(D) X 24MM | In distribution |
| 1200-0089 | ALTIUS CROSS CONNECTOR 68MM | In distribution |
| 1200-0088 | ALTIUS CROSS CONNECTOR 66MM | In distribution |
| 1200-0092 | 8CM X 3.5MM DIA. | In distribution |
| 1200-2134 | 3.5MM(D) X 34MM SMOOTH SHANK | In distribution |
| 1200-1148 | 4.0 X 48MM | In distribution |
| 1200-1732 | 4.74MM(D) X 32MM | In distribution |
| 1200-1112 | 4.0MM (D) X 12MM | In distribution |
| 1200-1120 | 4.0MM (D) X 20MM | In distribution |
| 1200-2122 | 3.5MM(D) X 22MM SMOOTH SHANK | In distribution |
| 1200-1116 | 4.0MM (D) X 16MM | In distribution |
| 1200-2144 | 3.5MM(D) X 44MM SMOOTH SHANK | In distribution |
| 1200-2128 | 3.5MM(D) X 28MM SMOOTH SHANK | In distribution |
| 1200-2000 | ALTIUS HOOK -RIGHT | In distribution |
| 1200-1132 | 4.0MM (D) X 32MM | In distribution |
| 1200-2003 | ALTIUS EXTENDED HOOK – LEFT | In distribution |
| 1200-3110 | ALTIUS TI CAP NUT | In distribution |
| 1200-2136 | 3.5MM(D) X 36MM SMOOTH SHANK | In distribution |
| 1200-1010 | 3.5MM (D) X 10MM | In distribution |
| 1200-1046 | 3.5MM X 46MM | In distribution |
| 1200-1136 | 4.0MM (D) X 36MM | In distribution |
| 1200-2124 | 3.5MM(D) X 24MM SMOOTH SHANK | In distribution |
| 1200-1720 | 4.75MM(D) X 20MM | In distribution |
| 1200-1050 | 3.5MM X 50MM | In distribution |
| 1200-1030 | 3.5MM X 30MM | In distribution |
| 1200-3135 | 35 – 45MM | In distribution |
| 1200-1736 | 4.75 X 36MM | In distribution |
| 1200-1024 | 3.5MM X 24MM | In distribution |
| 1200-2148 | 3.5MM(D) X 48MM SMOOTH SHANK | In distribution |
| 1200-1020 | 3.5MM (D) X 20MM | In distribution |
| 1200-1034 | 3.5MM X 34MM | In distribution |
| 1200-1032 | 3.5MM X 32MM | In distribution |
| 1200-1150 | 4.0 X 50MM | In distribution |
| 1200-1044 | 3.5MM X 44MM | In distribution |
| 1200-1142 | 4.0MM X 42MM | In distribution |
| 1200-1110 | 4.0MM (D) X 10MM | In distribution |
| 1200-2146 | 3.5MM(D) X 46MM SMOOTH SHANK | In distribution |
| 1200-0085 | ALTIUS CROSS CONNECTOR 60MM | In distribution |
| 1200-0087 | ALTIUS CROSS CONNECTOR 64MM | In distribution |
| 1200-2120 | 3.5MM(D) X 20MM SMOOTH SHANK | In distribution |
| 1200-1114 | 4.0MM (D) X 14MM | In distribution |
| 1200-2130 | 3.5MM(D) X 30MM SMOOTH SHANK | In distribution |
| 1200-1738 | 4.75 X 38MM | In distribution |
| 1200-0090 | ALTIUS CROSS CONNECTOR 70MM | In distribution |
| 1200-1012 | 3.5MM (D) X 12MM | In distribution |
| 1200-1008 | 3.5MM (D) X 8MM | In distribution |
| 1200-0098 | 24CM X 3.5MM DIA. | In distribution |
| 1200-2126 | 3.5MM(D) X 26MM SMOOTH SHANK | In distribution |
| 1200-1744 | 4.75 X 44MM | In distribution |
| 1200-2138 | 3.5MM(D) X 38MM SMOOTH SHANK | In distribution |
| 1200-1040 | 3.5MM X 40MM | In distribution |
| 1200-1036 | 3.5MM X 36MM | In distribution |
| 1200-2140 | 3.5MM(D) X 40MM SMOOTH SHANK | In distribution |
| 1200-1740 | 4.75 X 40MM | In distribution |
| 1200-1014 | 3.5MM (D) X 14MM | In distribution |
| 1200-1128 | 4.0MM (D) X 28MM | In distribution |
| 1200-1108 | 4.0MM (D) X 8MM | In distribution |
| 1200-1134 | 4.0 X 34MM | In distribution |
| 1200-1028 | 3.5MM X 28MM | In distribution |
| 1200-1750 | 4.75 X 50MM | In distribution |
| 1200-1742 | 4.75 X 42MM | In distribution |
| 1200-1038 | 3.5MM X 38MM | In distribution |
| 1200-1728 | 4.75MM(D) X 28MM | In distribution |
| 1200-3140 | 40 – 50MM | In distribution |
| 1200-1042 | 3.5MM X 42MM | In distribution |
| 1200-1026 | 3.5MM X 26MM | In distribution |
| 1200-2150 | 3.5MM(D) X 50MM SMOOTH SHANK | In distribution |
| 1200-1140 | 4.0MM (D) X 40MM | In distribution |
| 1200-1124 | 4.0MM (D) X 24MM | In distribution |
| 1200-1022 | 3.5MM X 22MM | In distribution |
| 1200-1144 | 4.0MM X 44MM | In distribution |
| 1200-2002 | ALTIUS EXTENDED HOOK – RIGHT | In distribution |
| 1200-1118 | 4.0MM (D) X 18MM | In distribution |
| 1200-1734 | 4.75 X 34MM | In distribution |
| 1200-1748 | 4.75 X 48MM | In distribution |
| 1200-0095 | 18CM X 3.5MM DIA | In distribution |
| 1200-1146 | 4.0 X 46MM | In distribution |
| 1200-1138 | 4.0 X 38MM | In distribution |
| 1200-1746 | 4.75 X 46MM | In distribution |
| 1200-0086 | ALTIUS CROSS CONNECTOR 62MM | In distribution |
| 1200-2001 | ALTIUS HOOK – LEFT | In distribution |
| 1200-3130 | 30 – 40MM | In distribution |
| 1200-2132 | 3.5MM(D) X 32MM SMOOTH SHANK | In distribution |
| 1200-1048 | 3.5MM X 48MM | In distribution |
| 1200-1122 | 4.0 X 22MM | In distribution |
| 1200-1018 | 3.5MM (D) X 18MM | In distribution |
| 1200-2142 | 3.5MM(D) X 42MM SMOOTH SHANK | In distribution |
| 1200-1016 | 3.5MM (D) X 16MM | 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.