Altius™ OCT Posterior Spinal System
90 catalogue numbers from 1200-1132, 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
90catalogue 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 | 2020-06-23 |
| Record revised | 2025-07-02 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1200-1132 | ALTIUS CANCELLOUS BONE SCREW 4.0MM (D) X 32MM | In distribution |
| 1200-1030 | CANCELLOUS BONE SCREW 3.5MM X 30MM | In distribution |
| 1200-1738 | CANCELLOUS BONE SCREW 4.75 X 38MM | In distribution |
| 1200-1740 | CANCELLOUS BONE SCREW 4.75 X 40MM | In distribution |
| 1200-1720 | ALTIUS CANCELLOUS BONE SCREW 4.75MM(D) X 20MM | In distribution |
| 1200-2138 | ALTIUS CANCELLOUS BONE SCREW 3.5MM(D) X 38MM SMOOTH SHANK | In distribution |
| 1200-1018 | ALTIUS CANCELLOUS BONE SCREW 3.5MM (D) X 18MM | In distribution |
| 1200-1032 | CANCELLOUS BONE SCREW 3.5MM X 32MM | In distribution |
| 1200-1728 | ALTIUS CANCELLOUS BONE SCREW 4.75MM(D) X 28MM | In distribution |
| 1200-0049M | ALTIUS SCREW CONNECTOR – FIXED | In distribution |
| 1200-1046 | CANCELLOUS BONE SCREW 3.5MM X 46MM | In distribution |
| 1200-0092 | ROD W/FLAT – 8CM X 3.5MM DIA. | In distribution |
| 1200-1112 | ALTIUS CANCELLOUS BONE SCREW 4.0MM (D) X 12MM | In distribution |
| 1200-1122 | CANCELLOUS BONE SCREW 4.0 X 22MM | In distribution |
| 1200-1010 | ALTIUS CANCELLOUS BONE SCREW 3.5MM (D) X 10MM | In distribution |
| 1200-1150 | CANCELLOUS BONE SCREW 4.0 X 50MM | In distribution |
| 1200-2136 | ALTIUS CANCELLOUS BONE SCREW 3.5MM(D) X 36MM SMOOTH SHANK | In distribution |
| 1200-1120 | ALTIUS CANCELLOUS BONE SCREW 4.0MM (D) X 20MM | In distribution |
| 1200-1144 | CANCELLOUS BONE SCREW 4.0MM X 44MM | In distribution |
| 1200-1146 | CANCELLOUS BONE SCREW 4.0 X 46MM | In distribution |
| 1200-2000 | ALTIUS HOOK -RIGHT | In distribution |
| 1200-1014 | ALTIUS CANCELLOUS BONE SCREW 3.5MM (D) X 14MM | In distribution |
| 1200-0051M | ALTIUS SCREW CONNECTOR 15 DEGREE – RIGHT | In distribution |
| 1200-2003 | ALTIUS EXTENDED HOOK – LEFT | In distribution |
| 1200-0052M | ALTIUS SCREW CONNECTOR 15 DEGREE – LEFT | In distribution |
| 1200-0048M | ALTIUS SCREW CONNECTOR – OPEN | In distribution |
| 1200-1128 | ALTIUS CANCELLOUS BONE SCREW 4.0MM (D) X 28MM | In distribution |
| 1200-2001 | ALTIUS HOOK – LEFT | In distribution |
| 1200-0051 | SCREW CONNECTOR – 15 DEG. R | In distribution |
| 1200-2124 | ALTIUS CANCELLOUS BONE SCREW 3.5MM(D) X 24MM SMOOTH SHANK | In distribution |
| 1200-1110 | ALTIUS CANCELLOUS BONE SCREW 4.0MM (D) X 10MM | In distribution |
| 1200-2126 | ALTIUS CANCELLOUS BONE SCREW 3.5MM(D) X 26MM SMOOTH SHANK | In distribution |
| 1200-1140 | ALTIUS CANCELLOUS BONE SCREW 4.0MM (D) X 40MM | In distribution |
| 1200-1034 | CANCELLOUS BONE SCREW 3.5MM X 34MM | In distribution |
| 1200-0098 | ROD W/FLAT 24CM X 3.5MM DIA. | In distribution |
| 1200-1024 | CANCELLOUS BONE SCREW 3.5MM X 24MM | In distribution |
| 1200-1748 | CANCELLOUS BONE SCREW 4.75 X 48MM | In distribution |
| 1200-0052 | SCREW CONNECTOR – 15 DEG. L | In distribution |
| 1200-1744 | CANCELLOUS BONE SCREW 4.75 X 44MM | In distribution |
| 1200-2144 | ALTIUS CANCELLOUS BONE SCREW 3.5MM(D) X 44MM SMOOTH SHANK | In distribution |
| 1200-2128 | ALTIUS CANCELLOUS BONE SCREW 3.5MM(D) X 28MM SMOOTH SHANK | In distribution |
| 1200-0056M | ALTIUS SCREW CONNECTOR 45 DEGREE – LEFT | In distribution |
| 1200-2132 | ALTIUS CANCELLOUS BONE SCREW 3.5MM(D) X 32MM SMOOTH SHANK | In distribution |
| 1200-1042 | CANCELLOUS BONE SCREW 3.5MM X 42MM | In distribution |
| 1200-1138 | CANCELLOUS BONE SCREW 4.0 X 38MM | In distribution |
| 1200-0054M | ALTIUS SCREW CONNECTOR 30 DEGREE – LEFT | In distribution |
| 1200-1118 | ALTIUS CANCELLOUS BONE SCREW 4.0MM (D) X 18MM | In distribution |
| 1200-1022 | CANCELLOUS BONE SCREW 3.5MM X 22MM | In distribution |
| 1200-1148 | CANCELLOUS BONE SCREW 4.0 X 48MM | In distribution |
| 1200-0055M | ALTIUS SCREW CONNECTOR 45 DEGREE – RIGHT | In distribution |
| 1200-1116 | ALTIUS CANCELLOUS BONE SCREW 4.0MM (D) X 16MM | In distribution |
| 1200-1048 | CANCELLOUS BONE SCREW 3.5MM X 48MM | In distribution |
| 1200-1742 | CANCELLOUS BONE SCREW 4.75 X 42MM | In distribution |
| 1200-1746 | CANCELLOUS BONE SCREW 4.75 X 46MM | In distribution |
| 1200-1008 | ALTIUS CANCELLOUS BONE SCREW 3.5MM (D) X 8MM | In distribution |
| 1200-0050M | ALTIUS SCREW CONNECTOR 0 DEGREE | In distribution |
| 1200-1142 | CANCELLOUS BONE SCREW 4.0MM X 42MM | In distribution |
| 1200-1108 | ALTIUS CANCELLOUS BONE SCREW 4.0MM (D) X 8MM | In distribution |
| 1200-2148 | ALTIUS CANCELLOUS BONE SCREW 3.5MM(D) X 48MM SMOOTH SHANK | In distribution |
| 1200-2142 | ALTIUS CANCELLOUS BONE SCREW 3.5MM(D) X 42MM SMOOTH SHANK | In distribution |
| 1200-2134 | ALTIUS CANCELLOUS BONE SCREW 3.5MM(D) X 34MM SMOOTH SHANK | In distribution |
| 1200-1124 | ALTIUS CANCELLOUS BONE SCREW 4.0MM (D) X 24MM | In distribution |
| 1200-1050 | CANCELLOUS BONE SCREW 3.5MM X 50MM | In distribution |
| 1200-0053M | ALTIUS SCREW CONNECTOR 30 DEGREE – RIGHT | In distribution |
| 1200-1734 | CANCELLOUS BONE SCREW 4.75 X 34MM | In distribution |
| 1200-1038 | CANCELLOUS BONE SCREW 3.5MM X 38MM | In distribution |
| 1200-3110 | ALTIUS CAP NUT | In distribution |
| 1200-1012 | ALTIUS CANCELLOUS BONE SCREW 3.5MM (D) X 12MM | In distribution |
| 1200-1044 | CANCELLOUS BONE SCREW 3.5MM X 44MM | In distribution |
| 1200-2120 | ALTIUS CANCELLOUS BONE SCREW 3.5MM(D) X 20MM SMOOTH SHANK | In distribution |
| 1200-2122 | ALTIUS CANCELLOUS BONE SCREW 3.5MM(D) X 22MM SMOOTH SHANK | In distribution |
| 1200-1020 | ALTIUS CANCELLOUS BONE SCREW 3.5MM (D) X 20MM | In distribution |
| 1200-0033 | ALTIUS LOCKING NUT | In distribution |
| 1200-2150 | ALTIUS CANCELLOUS BONE SCREW 3.5MM(D) X 50MM SMOOTH SHANK | In distribution |
| 1200-1732 | ALTIUS CANCELLOUS BONE SCREW 4.74MM(D) X 32MM | In distribution |
| 1200-1016 | ALTIUS CANCELLOUS BONE SCREW 3.5MM (D) X 16MM | In distribution |
| 1200-2130 | ALTIUS CANCELLOUS BONE SCREW 3.5MM(D) X 30MM SMOOTH SHANK | In distribution |
| 1200-1040 | CANCELLOUS BONE SCREW 3.5MM X 40MM | In distribution |
| 1200-1136 | ALTIUS CANCELLOUS BONE SCREW 4.0MM (D) X 36MM | In distribution |
| 1200-2146 | ALTIUS CANCELLOUS BONE SCREW 3.5MM(D) X 46MM SMOOTH SHANK | In distribution |
| 1200-1134 | CANCELLOUS BONE SCREW 4.0 X 34MM | In distribution |
| 1200-1724 | ALTIUS CANCELLOUS BONE SCREW 4.75MM(D) X 24MM | In distribution |
| 1200-1750 | CANCELLOUS BONE SCREW 4.75 X 50MM | In distribution |
| 1200-2002 | ALTIUS EXTENDED HOOK – RIGHT | In distribution |
| 1200-2140 | ALTIUS CANCELLOUS BONE SCREW 3.5MM(D) X 40MM SMOOTH SHANK | In distribution |
| 1200-1736 | CANCELLOUS BONE SCREW 4.75 X 36MM | In distribution |
| 1200-1028 | CANCELLOUS BONE SCREW 3.5MM X 28MM | In distribution |
| 1200-1026 | CANCELLOUS BONE SCREW 3.5MM X 26MM | In distribution |
| 1200-1114 | ALTIUS CANCELLOUS BONE SCREW 4.0MM (D) X 14MM | In distribution |
| 1200-1036 | CANCELLOUS BONE SCREW 3.5MM X 36MM | 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.