Tiger Spine OCT System
3500 Series Straight ROD - Cobalt Chrome With Line - 3.5MM X 100MM
13manufacturers in China registered for this device type
111catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 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 |
| 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 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spinal Pedicle Fixation
Record
| Listed by | Corelink, LLC, United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Record published | 2016-01-21 |
| 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 |
| Sizes | Outer diameter 3.5 to 4.5 mm; length 10 to 600 mm; angle 80 to 150 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 35945-30 | Length 30 mm | In distribution |
| R3501-100 | Outer Diameter 3.5 mm | In distribution |
| R3530-110 | Outer Diameter 3.5 mm | In distribution |
| R3503-065 | Outer Diameter 3.5 mm | In distribution |
| 35745-24 | Outer Diameter 4.5 mm | In distribution |
| 35940-24 | Outer Diameter 4 mm | In distribution |
| R3510-040 | Length 40 mm | In distribution |
| R3556-420 | Length 420 mm | In distribution |
| R3501-045 | Length 45 mm | In distribution |
| 35045-42 | Length 42 mm | In distribution |
| R3511-030 | Outer Diameter 3.5 mm | In distribution |
| 35740-16 | Outer Diameter 4 mm | In distribution |
| TC3650-56 | Length 56 mm | In distribution |
| R3513-100 | Length 100 mm | In distribution |
| R3503-085 | Outer Diameter 3.5 mm | In distribution |
| 35835-12 | Length 12 mm | In distribution |
| 35845-30 | Outer Diameter 4.5 mm | In distribution |
| R3501-080 | Length 80 mm | In distribution |
| 35035-36 | Length 36 mm | In distribution |
| R3502-060 | Outer Diameter 3.5 mm | In distribution |
| R3530-140 | Angle 140 ° | In distribution |
| R3555-600 | Length 600 mm | In distribution |
| 35745-10 | Outer Diameter 4.5 mm | In distribution |
| 35045-34 | Outer Diameter 4.5 mm | In distribution |
| 35003-12 | In distribution | |
| R3502-040 | Length 40 mm | In distribution |
| 35301-85 | In distribution | |
| 35745-20 | Outer Diameter 4.5 mm | In distribution |
| R3512-030 | Length 30 mm | In distribution |
| 35835-26 | Outer Diameter 3.5 mm | In distribution |
| R3501-070 | Length 70 mm | In distribution |
| 35945-40 | Length 40 mm | In distribution |
| R3513-035 | Length 35 mm | In distribution |
| 35045-26 | Length 26 mm | In distribution |
| R3531-090 | Angle 90 ° | In distribution |
| 35035-12 | Outer Diameter 3.5 mm | In distribution |
| 35845-26 | Length 26 mm | In distribution |
| 35940-22 | Length 22 mm | In distribution |
| 35045-30 | Outer Diameter 4.5 mm | In distribution |
| 35040-12 | Length 12 mm | In distribution |
| 35035-30 | Length 30 mm | In distribution |
| R3503-080 | Length 80 mm | In distribution |
| R3512-080 | Length 80 mm | In distribution |
| 35040-28 | Length 28 mm | In distribution |
| 35035-18 | Outer Diameter 3.5 mm | In distribution |
| R3531-095 | Angle 95 ° | In distribution |
| R3501-095 | Outer Diameter 3.5 mm | In distribution |
| TC3630-36 | Length 36 mm | In distribution |
| 35040-34 | Outer Diameter 4 mm | In distribution |
| 35140-14 | Outer Diameter 4 mm | In distribution |
| R3513-030 | Outer Diameter 3.5 mm | In distribution |
| R3530-150 | Angle 150 ° | In distribution |
| R3502-065 | Outer Diameter 3.5 mm | In distribution |
| R3502-070 | Outer Diameter 3.5 mm | In distribution |
| 35035-42 | Outer Diameter 3.5 mm | In distribution |
| 35845-28 | Length 28 mm | In distribution |
| 35035-20 | Outer Diameter 3.5 mm | In distribution |
| R3501-055 | Outer Diameter 3.5 mm | In distribution |
| 35035-28 | Outer Diameter 3.5 mm | In distribution |
| 35745-12 | Length 12 mm | In distribution |
| 35140-16 | Outer Diameter 4 mm | In distribution |
| 35302-16 | In distribution | |
| 35835-20 | Outer Diameter 3.5 mm | In distribution |
| TC3526-37 | Length 37 mm | In distribution |
| R3501-040 | Outer Diameter 3.5 mm | In distribution |
| 35835-14 | Outer Diameter 3.5 mm | In distribution |
| 35935-24 | Outer Diameter 3.5 mm | In distribution |
| 35235-40 | In distribution | |
| R3502-035 | Outer Diameter 3.5 mm | In distribution |
| 35735-26 | Length 26 mm | In distribution |
| 35035-10 | Length 10 mm | In distribution |
| R3501-060 | Outer Diameter 3.5 mm | In distribution |
| R3555-420 | Length 420 mm | In distribution |
| R3502-075 | Outer Diameter 3.5 mm | In distribution |
| 35940-34 | Outer Diameter 4 mm | In distribution |
| R3513-045 | Length 45 mm | In distribution |
| R3511-025 | Length 25 mm | In distribution |
| R3531-140 | Outer Diameter 3.5 mm | In distribution |
| 35745-16 | Outer Diameter 4.5 mm | In distribution |
| 35035-24 | Outer Diameter 3.5 mm | In distribution |
| R3530-135 | Outer Diameter 3.5 mm | In distribution |
| 35003-13 | In distribution | |
| 35840-34 | Length 34 mm | In distribution |
| R3503-060 | Outer Diameter 3.5 mm | In distribution |
| 35935-20 | Length 20 mm | In distribution |
| 35255-10 | In distribution | |
| 35940-26 | Length 26 mm | In distribution |
| 35635-75 | In distribution | |
| 35845-20 | Length 20 mm | In distribution |
| 35940-38 | Length 38 mm | In distribution |
| TC3645-51 | Length 51 mm | In distribution |
| R3510-130 | Length 130 mm | In distribution |
| 35835-22 | Outer Diameter 3.5 mm | In distribution |
| 35940-28 | Length 28 mm | In distribution |
| R3530-115 | Angle 115 ° | In distribution |
| 35745-14 | Outer Diameter 4.5 mm | In distribution |
| 35945-32 | Length 32 mm | In distribution |
| R3530-100 | Outer Diameter 3.5 mm | In distribution |
| R3531-080 | Angle 80 ° | In distribution |
| TC3517-28 | Length 28 mm | In distribution |
| 35035-48 | Outer Diameter 3.5 mm | In distribution |
| 35840-20 | Length 20 mm | In distribution |
| R3513-130 | Length 130 mm | In distribution |
| 35935-40 | Outer Diameter 3.5 mm | In distribution |
| R3501-050 | Length 50 mm | In distribution |
| R3500-060 | Outer Diameter 3.5 mm | In distribution |
| R3531-085 | Outer Diameter 3.5 mm | In distribution |
| 35840-16 | Length 16 mm | In distribution |
| R3503-100 | Outer Diameter 3.5 mm | In distribution |
| 35740-18 | Outer Diameter 4 mm | In distribution |
| 35745-18 | Length 18 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K120696 | 2012-04-02 |
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.