Tiger Spine System
5500 Series Lateral Connector - Neutral Offset, 200MM - Closed, Rounded
15manufacturers in China registered for this device type
365catalogue numbers in this listing
6510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Corelink, LLC, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Record published | 2014-09-19 |
| 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, manufacturing date |
| Sizes | Length 16 to 500 mm; outer diameter 4.5 to 10.5 mm; angle 75 to 105 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 77695-120 | Length 120 mm | In distribution |
| 61065-70 | Outer Diameter 6.5 mm | In distribution |
| 61185-40 | Length 40 mm | In distribution |
| R55060-150 | Length 150 mm | In distribution |
| 61165-80 | Length 80 mm | In distribution |
| 77505-90 | Length 90 mm | In distribution |
| 77375-80 | Length 80 mm | In distribution |
| R55080-40 | Length 40 mm | In distribution |
| 60430-00 | In distribution | |
| 77375-30 | Length 30 mm | In distribution |
| 55000-24 | In distribution | |
| R55070-80 | Length 80 mm | In distribution |
| R55060-45 | Length 45 mm | In distribution |
| 61205-01 | In distribution | |
| R5512-035 | Length 35.0 mm | In distribution |
| 77695-40 | Length 40 mm | In distribution |
| 61165-25 | Outer Diameter 6.5 mm | In distribution |
| 77695-50 | Length 50 mm | In distribution |
| 60155-40 | Length 40 mm | In distribution |
| 61075-60 | Outer Diameter 7.5 mm | In distribution |
| R5514-065 | Length 65.0 mm | In distribution |
| 77375-120 | Length 120 mm | In distribution |
| 61400-00 | In distribution | |
| 77655-55 | Length 55 mm | In distribution |
| 77695-70 | Outer Diameter 9.5 mm | In distribution |
| 60165-35 | Outer Diameter 6.5 mm | In distribution |
| R5515-500 | Length 500.0 mm | In distribution |
| 77505-45 | Length 45 mm | In distribution |
| 61175-45 | Outer Diameter 7.5 mm | In distribution |
| 77875-70 | Outer Diameter 7.5 mm | In distribution |
| 55855-30 | Outer Diameter 5.5 mm | In distribution |
| 77875-30 | Length 30 mm | In distribution |
| 61165-45 | Outer Diameter 6.5 mm | In distribution |
| 61165-50 | Outer Diameter 6.5 mm | In distribution |
| 77865-30 | Length 30 mm | In distribution |
| 77365-50 | Length 50 mm | In distribution |
| R55090-40 | Length 40 mm | In distribution |
| R5511-110 | Length 110.0 mm | In distribution |
| 60055-55 | Length 55.0 mm | In distribution |
| 77505-35 | Length 35 mm | In distribution |
| 61185-25 | Outer Diameter 8.5 mm | In distribution |
| 77865-40 | Length 40 mm | In distribution |
| 77675-60 | Length 60 mm | In distribution |
| R5514-130 | Length 130.0 mm | In distribution |
| R55090-60 | Length 60 mm | In distribution |
| 77505-55 | Length 55 mm | In distribution |
| R5513-200 | Length 200.0 mm | In distribution |
| 77875-100 | Length 100 mm | In distribution |
| R5511-130 | Length 130.0 mm | In distribution |
| 61055-45 | Outer Diameter 5.5 mm | In distribution |
| 55321-60 | Length 60 mm | In distribution |
| 77655-35 | Length 35 mm | In distribution |
| 60155-55 | Outer Diameter 5.5 mm | In distribution |
| R55070-70 | Length 70 mm | In distribution |
| 60200-02 | EXTENDED | In distribution |
| 77375-25 | Outer Diameter 7.5 mm | In distribution |
| 60085-50 | Length 50 mm | In distribution |
| 77855-35 | Outer Diameter 5.5 mm | In distribution |
| 77595-60 | Length 60 mm | In distribution |
| R55070-90 | Length 90 mm | In distribution |
| 61200-02 | EXTENDED | In distribution |
| 55855-55 | Outer Diameter 5.5 mm | In distribution |
| 77565-60 | Outer Diameter 6.5 mm | In distribution |
| R55090-70 | Length 70 mm | In distribution |
| 77375-50 | Length 50 mm | In distribution |
| 77375-100 | Length 100 mm | In distribution |
| TC5525-30 | Length 25.0 mm | In distribution |
| 60220-00 | MINI | In distribution |
| 77865-50 | Length 50 mm | In distribution |
| 60055-35 | Length 35.0 mm | In distribution |
| R55080-110 | Length 110 mm | In distribution |
| 77855-30 | Length 30 mm | In distribution |
| 77585-100 | Outer Diameter 8.5 mm | In distribution |
| 77595-70 | Outer Diameter 9.5 mm | In distribution |
| 60205-01 | Standard | In distribution |
| 60075-35 | Outer Diameter 7.5 mm | In distribution |
| 61175-40 | Outer Diameter 7.5 mm | In distribution |
| 61085-70 | Outer Diameter 8.5 mm | In distribution |
| 77855-50 | Length 50 mm | In distribution |
| 77355-50 | Length 50 mm | In distribution |
| 60325-50 | Slot 33.5 mm | In distribution |
| 61075-70 | Outer Diameter 7.5 mm | In distribution |
| R55080-90 | Length 90 mm | In distribution |
| 55000-14 | In distribution | |
| 77865-30 | Length 30 mm | In distribution |
| R5510-070 | Length 70.0 mm | In distribution |
| 61055-55 | Outer Diameter 5.5 mm | In distribution |
| TC5537-50 | Length 37.0 mm | In distribution |
| R5511-300 | Length 300.0 mm | In distribution |
| 77865-60 | Length 60 mm | In distribution |
| R5510-140 | Length 140.0 mm | In distribution |
| 77675-35 | Length 35 mm | In distribution |
| 61075-25 | Outer Diameter 7.5 mm | In distribution |
| 60055-25 | Length 25.0 mm | In distribution |
| 60410-00 | In distribution | |
| 60065-25 | Outer Diameter 6.5 mm | In distribution |
| 77575-80 | Outer Diameter 7.5 mm | In distribution |
| R5511-045 | Length 45.0 mm | In distribution |
| 61075-40 | Outer Diameter 7.5 mm | In distribution |
| 77675-25 | Length 25 mm | In distribution |
| 77365-40 | Length 40 mm | In distribution |
| 55310-30 | Angle 75 ° | In distribution |
| 77565-40 | Outer Diameter 6.5 mm | In distribution |
| 77605-120 | Length 120 mm | In distribution |
| 77605-100 | Length 100 mm | In distribution |
| 61085-35 | Outer Diameter 8.5 mm | In distribution |
| R5512-055 | Length 55.0 mm | In distribution |
| R5511-065 | Length 65.0 mm | In distribution |
| 77365-50 | Length 50 mm | In distribution |
| R55060-35 | Length 35 mm | In distribution |
| 77865-55 | Outer Diameter 6.5 mm | In distribution |
| 61085-45 | Outer Diameter 8.5 mm | In distribution |
| TC5500-16 | Length 16.0 mm | In distribution |
| R55090-50 | Length 50 mm | In distribution |
| 77665-35 | Length 35 mm | In distribution |
| 60065-45 | Outer Diameter 6.5 mm | In distribution |
| 61075-90 | Outer Diameter 7.5 mm | In distribution |
| 61165-45 | Length 45 mm | In distribution |
| 77865-60 | Length 60 mm | In distribution |
| 77875-60 | Length 60 mm | In distribution |
| 60220-01 | In distribution | |
| 55000-23 | In distribution | |
| 61165-30 | Length 30 mm | In distribution |
| 77555-40 | Outer Diameter 5.5 mm | In distribution |
| 61225-01 | STANDARD | In distribution |
| 61085-55 | Outer Diameter 8.5 mm | In distribution |
| 77875-80 | Length 80 mm | In distribution |
| 60200-00 | In distribution | |
| 77675-80 | Length 80 mm | In distribution |
| R5510-120 | Length 120.0 mm | In distribution |
| 77685-100 | Length 100 mm | In distribution |
| 60065-60 | Length 60 mm | In distribution |
| R55090-110 | Length 110 mm | In distribution |
| 77545-25 | Outer Diameter 4.5 mm | In distribution |
| R5513-400 | Length 400.0 mm | In distribution |
| 60155-25 | Outer Diameter 5.5 mm | In distribution |
| 60165-25 | Length 25 mm | In distribution |
| 61155-45 | Outer Diameter 5.5 mm | In distribution |
| 60085-40 | Outer Diameter 8.5 mm | In distribution |
| 77555-40 | Length 40 mm | In distribution |
| 60225-00 | MINI | In distribution |
| 77585-40 | Outer Diameter 8.5 mm | In distribution |
| R5514-075 | Length 75.0 mm | In distribution |
| 60345-50 | Slot 3 33.5 mm | In distribution |
| 61225-01 | In distribution | |
| 61185-35 | Outer Diameter 8.5 mm | In distribution |
| 77585-80 | Outer Diameter 8.5 mm | In distribution |
| 61165-55 | Outer Diameter 6.5 mm | In distribution |
| 77595-40 | Outer Diameter 9.5 mm | In distribution |
| 55845-40 | Outer Diameter 4.5 mm | In distribution |
| 61175-25 | Outer Diameter 7.5 mm | In distribution |
| 77855-40 | Length 40 mm | In distribution |
| 77505-100 | Length 100 mm | In distribution |
| 77675-40 | Length 40 mm | In distribution |
| 77585-120 | Outer Diameter 8.5 mm | In distribution |
| R55080-130 | Length 130 mm | In distribution |
| 77575-60 | Outer Diameter 7.5 mm | In distribution |
| 77695-100 | Length 100 mm | In distribution |
| 61175-55 | Outer Diameter 7.5 mm | In distribution |
| 61085-110 | Outer Diameter 8.5 mm | In distribution |
| 61155-55 | Outer Diameter 5.5 mm | In distribution |
| 60085-45 | Outer Diameter 8.5 mm | In distribution |
| 77695-55 | Outer Diameter 9.5 mm | In distribution |
| 60065-55 | Outer Diameter 6.5 mm | In distribution |
| 77605-40 | Length 40 mm | In distribution |
| 77555-50 | Outer Diameter 5.5 mm | In distribution |
| 60085-55 | Outer Diameter 8.5 mm | In distribution |
| R5511-150 | Length 150.0 mm | In distribution |
| 61185-55 | Outer Diameter 8.5 mm | In distribution |
| 77665-30 | Length 30 mm | In distribution |
| 77685-60 | Length 60 mm | In distribution |
| R5510-080 | Length 80.0 mm | In distribution |
| 60320-16 | Slot 6.6 mm | In distribution |
| 60320-33 | In distribution | |
| 55875-30 | Outer Diameter 7.5 mm | In distribution |
| R55090-300 | Length 300 mm | In distribution |
| R55060-65 | Length 65 mm | In distribution |
| R5511-035 | Length 35.0 mm | In distribution |
| R5515-300 | Length 300.0 mm | In distribution |
| 60210-00 | MINI | In distribution |
| 61075-30 | Length 30 mm | In distribution |
| 61175-70 | Outer Diameter 7.5 mm | In distribution |
| R5516-200 | Length 200.0 mm | In distribution |
| 61085-30 | Outer Diameter 8.5 mm | In distribution |
| 61085-25 | Outer Diameter 8.5 mm | In distribution |
| 61155-40 | Length 40 mm | In distribution |
| 77355-40 | Length 40 mm | In distribution |
| 77665-25 | Length 25 mm | In distribution |
| 77655-45 | Length 45 mm | In distribution |
| 60200-00 | Mini | In distribution |
| 77595-55 | Outer Diameter 9.5 mm | In distribution |
| 77865-45 | Outer Diameter 6.5 mm | In distribution |
| 60175-25 | Outer Diameter 7.5 mm | In distribution |
| R5510-090 | Length 90.0 mm | In distribution |
| 77505-45 | Outer Diameter 10.5 mm | In distribution |
| 61185-45 | Outer Diameter 8.5 mm | In distribution |
| 77665-45 | Length 45 mm | In distribution |
| 77665-40 | Outer Diameter 6.5 mm | In distribution |
| 77605-50 | Length 50 mm | In distribution |
| R55090-90 | Length 90 mm | In distribution |
| 77685-40 | Length 40 mm | In distribution |
| 77565-55 | Length 55 mm | In distribution |
| 60065-45 | Outer Diameter 6.5 mm | In distribution |
| 61065-55 | Outer Diameter 6.5 mm | In distribution |
| R5511-095 | Length 95.0 mm | In distribution |
| 61165-35 | Outer Diameter 6.5 mm | In distribution |
| 77675-100 | Length 100 mm | In distribution |
| 61205-01 | STANDARD | In distribution |
| 61155-25 | Outer Diameter 5.5 mm | In distribution |
| 77565-60 | Outer Diameter 6.5 mm | In distribution |
| R5511-055 | Length 55.0 mm | In distribution |
| 61220-01 | STANDARD | In distribution |
| 55355-45 | Outer Diameter 5.5 mm | In distribution |
| 61055-45 | Outer Diameter 5.5 mm | In distribution |
| R5514-035 | Length 35.0 mm | In distribution |
| 61185-70 | Outer Diameter 8.5 mm | In distribution |
| 77355-45 | Length 45 mm | In distribution |
| 61185-90 | Outer Diameter 8.5 mm | In distribution |
| 61185-90 | Length 90 mm | In distribution |
| 77375-40 | Length 40 mm | In distribution |
| 60185-50 | Outer Diameter 8.5 mm | In distribution |
| R55080-150 | Length 150 mm | In distribution |
| 77695-45 | Length 45 mm | In distribution |
| R55090-150 | Length 150 mm | In distribution |
| 61185-80 | Outer Diameter 8.5 mm | In distribution |
| 77875-110 | Length 110 mm | In distribution |
| 55301-60 | Length 60 mm | In distribution |
| 77675-120 | Length 120 mm | In distribution |
| 55875-80 | Outer Diameter 7.5 mm | In distribution |
| 60330-20 | In distribution | |
| 55875-50 | Length 50 mm | In distribution |
| 77875-120 | Length 120 mm | In distribution |
| 77685-40 | Length 40 mm | In distribution |
| 77555-30 | Length 30 mm | In distribution |
| 77365-55 | Outer Diameter 6.5 mm | In distribution |
| 55000-18 | In distribution | |
| 61215-01 | STANDARD | In distribution |
| R5512-045 | Length 45.0 mm | In distribution |
| R5514-095 | Length 95.0 mm | In distribution |
| TC5500-20 | Length 20.0 mm | In distribution |
| 61055-35 | Outer Diameter 5.5 mm | In distribution |
| 77595-90 | Length 90 mm | In distribution |
| 60085-35 | Outer Diameter 8.5 mm | In distribution |
| 61085-90 | Outer Diameter 8.5 mm | In distribution |
| 60225-01 | In distribution | |
| 60325-33 | In distribution | |
| 77675-50 | Length 50 mm | In distribution |
| 60330-50 | Slot 20 mm | In distribution |
| 61185-110 | Outer Diameter 8.5 mm | In distribution |
| R55060-110 | Length 110 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221776 | 2022-08-09 |
| K210539 | 2021-04-15 |
| K133369 | 2014-01-14 |
| K131250 | 2013-09-10 |
| K121728 | 2012-10-05 |
| K113058 | 2012-03-29 |
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.