Altius M-INI OCT Spine SYS.
125 catalogue numbers from 1200-0036, 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
125catalogue 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 |
|---|---|---|
| 1200-0036 | ADJUSTABLE – LEFT | In distribution |
| 1200-2826 | 4.0MM(D) X 26MM(L) | In distribution |
| 1200-2936 | 4.5MM X 36MM | In distribution |
| 1200-2422 | 3.5MM(D) X 22MM(L) | In distribution |
| 1200-0013 | 3.5MM / 5.5MM | In distribution |
| 1200-2710 | 3.5MM(D) X 10MM(L) | In distribution |
| 1200-2760 | HOOK 4.5MM | In distribution |
| 1200-3020 | 5.0MM (D) X 20MM (L) | In distribution |
| 1200-0070 | ALTIUS CROSS CONNECTOR 30MM | In distribution |
| 1200-3230 | 30MM- 40MM | In distribution |
| 1200-2430 | 3.5MM(D) X 30MM(L) | In distribution |
| 1200-0065 | ALTIUS CROSS CONNECTOR 20MM | In distribution |
| 1200-2448 | 3.5MM(D) X 48MM(L) | In distribution |
| 1200-2440 | 3.5MM(D) X 40MM(L) | In distribution |
| 1200-0016 | ALTIUS M-INI CURVED ROD 12CM | In distribution |
| 1200-0051 | 15 DEG. R | In distribution |
| 1200-0025 | TI ROD CONNECTOR 3.5MM / 5.5MM | In distribution |
| 1200-0048M | ALTIUS SCREW CONNECTOR – OPEN | In distribution |
| 1200-3240 | 40MM – 50MM | In distribution |
| 1200-0068 | ALTIUS CROSS CONNECTOR 26MM | In distribution |
| 1200-0071 | ALTIUS CROSS CONNECTOR 32MM | In distribution |
| 1200-0054M | 30 DEGREE – LEFT | In distribution |
| 1200-2722 | 3.5MM(D) X 22MM(L) | In distribution |
| 1200-0052 | 15 DEG. L | In distribution |
| 1200-2716 | 3.5MM(D) X 16MM(L) | In distribution |
| 1200-0066 | ALTIUS CROSS CONNECTOR 22MM | In distribution |
| 1200-0075 | ALTIUS CROSS CONNECTOR 40MM | In distribution |
| 1200-0049M | ALTIUS SCREW CONNECTOR – FIXED | In distribution |
| 1200-0050M | 0 DEGREE | In distribution |
| 1200-2812 | 4.0MM(D) X 12MM(L) | In distribution |
| 1200-2940 | 4.5MM X 40MM | In distribution |
| 1200-2820 | 4.0MM(D) X 20MM(L) | In distribution |
| 1200-0015 | 3.5MM / 6.35MM | In distribution |
| 1200-2810 | 4.0MM(D) X 10MM(L) | In distribution |
| 1200-2428 | 3.5MM(D) X 28MM(L) | In distribution |
| 1200-3008 | 5.0MM (D) X 8MM (L) | In distribution |
| 1200-0035 | ADJUSTABLE – RIGHT | In distribution |
| 1200-2450 | 3.5MM(D) X 50MM(L) | In distribution |
| 1200-2606 | LATERAL CONNECTOR | In distribution |
| 1200-2605 | CONNECTOR | In distribution |
| 1200-3016 | 5.0MM (D) X 16MM (L) | In distribution |
| 1200-0076 | ALTIUS CROSS CONNECTOR 42MM | In distribution |
| 1200-0051M | 15 DEGREE – RIGHT | In distribution |
| 1200-2920 | 4.5MM(D) X 20MM(L) | In distribution |
| 1200-3235 | 35MM – 45MM | In distribution |
| 1200-2444 | 3.5MM(D) X 44MM(L) | In distribution |
| 1200-0027 | TI ROD CONNECTOR 3.5MM / 6.35MM | In distribution |
| 1200-2828 | 4.0MM(D) X 28MM(L) | In distribution |
| 1200-2436 | 3.5MM(D) X 36MM(L) | In distribution |
| 1200-0019 | 75 DEGREE | In distribution |
| 1200-0083 | ALTIUS CROSS CONNECTOR 56MM | In distribution |
| 1200-3010 | 5.0MM (D) X 10MM (L) | In distribution |
| 1200-2818 | 4.0MM(D) X 18MM(L) | In distribution |
| 1200-3014 | 5.0MM (D) X 14MM (L) | In distribution |
| 1200-0072 | ALTIUS CROSS CONNECTOR 34MM | In distribution |
| 1200-2836 | 4.0MM X 36MM | In distribution |
| 1200-2824 | 4.0MM(D) X 24MM(L) | In distribution |
| 1200-2830 | 4.0MM X 30MM | In distribution |
| 1200-3012 | 5.0MM (D) X 12MM (L) | In distribution |
| 1200-0022 | TI ROD CONNECTOR 3.5 / 4.75 | In distribution |
| 1200-0018 | 60 DEGREE | In distribution |
| 1200-2761 | HOOK 6.0MM | In distribution |
| 1200-0055M | 45 DEGREE – RIGHT | In distribution |
| 1200-0078 | ALTIUS CROSS CONNECTOR 46MM | In distribution |
| 1200-2720 | 3.5MM(D) X 20MM(L) | In distribution |
| 1200-0079 | ALTIUS CROSS CONNECTOR 48MM | In distribution |
| 1200-3011 | 5.0MM (D) X 11MM (L) | In distribution |
| 1200-0005 | ALTIUS 3.5MM DIA TI ROD 18CM | In distribution |
| 1200-0069 | ALTIUS CROSS CONNECTOR 28MM | In distribution |
| 1200-0080 | ALTIUS CROSS CONNECTOR 50MM | In distribution |
| 1200-2814 | 4.0MM(D) X 14MM(L) | In distribution |
| 1200-0020 | 3.5MM / 3.5MM | In distribution |
| 1200-0084 | ALTIUS CROSS CONNECTOR 58MM | In distribution |
| 1200-2714 | 3.5MM(D) X 14MM(L) | In distribution |
| 1200-3019 | 5.0MM (D) X 19MM (L) | In distribution |
| 1200-2840 | 4.0MM X 40MM | In distribution |
| 1200-2728 | 3.5MM X 28MM | In distribution |
| 1200-2420 | 3.5MM(D) X 20MM(L) | In distribution |
| 1200-0053M | 30 DEGREE – RIGHT | In distribution |
| 1200-2442 | 3.5MM(D) X 42MM(L) | In distribution |
| 1200-2816 | 4.0MM (D) X 16MM (L) | In distribution |
| 1200-3009 | 5.0MM (D) X 9MM (L) | In distribution |
| 1200-0077 | ALTIUS CROSS CONNECTOR 44MM | In distribution |
| 1200-2432 | 3.5MM(D) X 32MM(L) | In distribution |
| 1200-0023 | TI ROD CONNECTOR 3.5MM / 4.75MM | In distribution |
| 1200-0056M | 45 DEGREE – LEFT | In distribution |
| 1200-0067 | ALTIUS CROSS CONNECTOR 24MM | In distribution |
| 1200-2932 | 4.5MM(D) X 32MM(L) | In distribution |
| 1200-0011 | 3.5MM / 4.75MM | In distribution |
| 1200-0017 | ALTIUS 3.5 DIA CURVED ROD 12CM | In distribution |
| 1200-0052M | 15 DEGREE – LEFT | In distribution |
| 1200-0074 | ALTIUS CROSS CONNECTOR 38MM | In distribution |
| 1200-0073 | ALTIUS CROSS CONNECTOR 36MM | In distribution |
| 1200-0056 | 45 DEG. L | In distribution |
| 1200-0021 | 3.5MM / 3.5MM | In distribution |
| 1200-2434 | 3.5MM(D) X 34MM(L) | In distribution |
| 1200-2426 | 3.5MM(D) X 26MM(L) | In distribution |
| 1200-2924 | 4.5MM(D) X 24MM(L) | In distribution |
| 1200-3007 | 5.0MM (D) X 7MM (L) | In distribution |
| 1200-3006 | 5.0MM (D) X 6MM (L) | In distribution |
| 1200-0030 | TI TAPERED SET SCREW | In distribution |
| 1200-0008 | ALTIUS 3.5MM DIA TI ROD 24CM | In distribution |
| 1200-3018 | 5.0MM (D) X 18MM (L) | In distribution |
| 1200-2446 | 3.5MM(D) X 46MM(L) | In distribution |
| 1200-0001 | ALTIUS 3.5MM DIA TI ROD 6CM | In distribution |
| 1200-2712 | 3.5MM(D) X 12MM(L) | In distribution |
| 1200-2726 | 3.5MM X 26MM | In distribution |
| 1200-2601 | PLUG | In distribution |
| 1200-0033 | ALTIUS TI LOCKING NUT | In distribution |
| 1200-2928 | 4.5MM(D) X 28MM(L) | In distribution |
| 1200-0081 | ALTIUS CROSS CONNECTOR 52MM | In distribution |
| 1200-2718 | 3.5MM(D) X 18MM(L) | In distribution |
| 1200-3013 | 5.0MM (D) X 13MM (L) | In distribution |
| 1200-2822 | 4.0MM(D) X 22MM(L) | In distribution |
| 1200-2424 | 3.5MM(D) X 24MM(L) | In distribution |
| 1200-0002 | ALTIUS 3.5MM DIA TI ROD 8CM | In distribution |
| 1200-2724 | 3.5MM X 24MM | In distribution |
| 1200-2938 | 4.5MM X 38MM | In distribution |
| 1200-0049 | TI SCREW CONNECTOR – FIXED | In distribution |
| 1200-0082 | ALTIUS CROSS CONNECTOR 54MM | In distribution |
| 1200-2438 | 3.5MM(D) X 38MM(L) | In distribution |
| 1200-3017 | 5.0MM (D) X 17MM (L) | In distribution |
| 1200-0010 | 45 DEGREE | In distribution |
| 1200-0003 | ALTIUS 3.5MM DIA TI ROD 10CM | In distribution |
| 1200-3015 | 5.0MM (D) X 15MM (L) | 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.