Tiger Spine System
5500 Series Straight ROD - Cobalt Chrome With HEX & Line - 5.5MM X 600MM
13manufacturers in China registered for this device type
535catalogue 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, Spondylolisthesis Spinal Fixation
Record
| Listed by | Corelink, LLC, United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| 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 15 to 600 mm; outer diameter 4.5 to 10.5 mm; angle 75 to 105 °; lumen/inner diameter 6.35 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 55865-25 | Outer Diameter 6.5 mm | In distribution |
| 55865-35 | Outer Diameter 6.5 mm | In distribution |
| 60075-30 | Length 30 mm | In distribution |
| 77505-120 | Length 120 mm | In distribution |
| 55075-110 | Outer Diameter 7.5 mm | In distribution |
| 61185-35 | Outer Diameter 8.5 mm | In distribution |
| 55675-60 | Outer Diameter 7.5 mm | In distribution |
| R5503-300 | Outer Diameter 5.5 mm | In distribution |
| 77605-55 | Length 55 mm | In distribution |
| 55355-35 | Outer Diameter 5.5 mm | In distribution |
| 55320-60 | Angle 105 ° | In distribution |
| R5510-045 | Outer Diameter 5.5 mm | In distribution |
| 55475-35 | Length 35 mm | In distribution |
| 55065-25 | Length 25 mm | In distribution |
| 77875-120 | Length 120 mm | In distribution |
| R5513-600 | Outer Diameter 5.5 mm | In distribution |
| 60165-50 | Length 50 mm | In distribution |
| 55495-60 | Length 60 mm | In distribution |
| 55185-90 | Length 90 mm | In distribution |
| 77675-50 | Length 50 mm | In distribution |
| 55255-40 | Outer Diameter 5.5 mm | In distribution |
| R5500-085 | Length 85 mm | In distribution |
| 77655-60 | Outer Diameter 5.5 mm | In distribution |
| 55045-45 | Length 45 mm | In distribution |
| 61185-25 | Outer Diameter 8.5 mm | In distribution |
| 77595-90 | Outer Diameter 9.5 mm | In distribution |
| 55875-90 | Length 90 mm | In distribution |
| 55605-90 | Length 90 mm | In distribution |
| 55685-35 | Length 35 mm | In distribution |
| 60315-33 | In distribution | |
| 55080-40 | Outer Diameter 8 mm | In distribution |
| 55445-55 | Outer Diameter 4.5 mm | In distribution |
| 61055-55 | Outer Diameter 5.5 mm | In distribution |
| R5504-050 | Outer Diameter 5.5 mm | In distribution |
| R5508-090 | Length 90 mm | In distribution |
| 55065-30 | Length 30 mm | In distribution |
| 77585-50 | Length 50 mm | In distribution |
| 55055-50 | Length 50 mm | In distribution |
| 55475-25 | Outer Diameter 7.5 mm | In distribution |
| 55295-110 | Length 110 mm | In distribution |
| 61205-02 | In distribution | |
| 55355-55 | Outer Diameter 5.5 mm | In distribution |
| 55295-90 | Length 90 mm | In distribution |
| 55001-8 | Wide, Tall | In distribution |
| 55365-30 | Length 30 mm | In distribution |
| R5505-090 | Outer Diameter 5.5 mm | In distribution |
| 55375-100 | Outer Diameter 7.5 mm | In distribution |
| 55255-35 | Length 35 mm | In distribution |
| 55485-90 | Length 90 mm | In distribution |
| 55185-80 | Length 80 mm | In distribution |
| 55245-25 | Length 25 mm | In distribution |
| 55865-40 | Length 40 mm | In distribution |
| 55085-55 | Length 55 mm | In distribution |
| 77365-25 | Outer Diameter 6.5 mm | In distribution |
| 77695-40 | Length 40 mm | In distribution |
| R5502-070 | Outer Diameter 5.5 mm | In distribution |
| 55355-45 | Outer Diameter 5.5 mm | In distribution |
| 55065-35 | Outer Diameter 6.5 mm | In distribution |
| 61075-80 | Outer Diameter 7.5 mm | In distribution |
| 55245-30 | Outer Diameter 4.5 mm | In distribution |
| 55075-25 | Outer Diameter 7.5 mm | In distribution |
| 55175-120 | Outer Diameter 7.5 mm | In distribution |
| 55465-35 | Outer Diameter 6.5 mm | In distribution |
| 60065-40 | Length 40 mm | In distribution |
| 55070-35 | Length 35 mm | In distribution |
| 55855-35 | Outer Diameter 5.5 mm | In distribution |
| 77695-50 | Outer Diameter 9.5 mm | In distribution |
| 77505-60 | Outer Diameter 10.5 mm | In distribution |
| 55495-40 | Outer Diameter 9.5 mm | In distribution |
| 55275-60 | Length 60 mm | In distribution |
| 55285-110 | Outer Diameter 8.5 mm | In distribution |
| R5500-095 | Outer Diameter 5.5 mm | In distribution |
| 55345-60 | Outer Diameter 4.5 mm | In distribution |
| 60185-30 | Outer Diameter 8.5 mm | In distribution |
| 55485-110 | Outer Diameter 8.5 mm | In distribution |
| 60055-35 | Outer Diameter 5.5 mm | In distribution |
| 55585-55 | Length 55 mm | In distribution |
| 77865-25 | Outer Diameter 6.5 mm | In distribution |
| 61055-35 | Outer Diameter 5.5 mm | In distribution |
| 55695-40 | Length 40 mm | In distribution |
| 55485-50 | Length 50 mm | In distribution |
| 55055-35 | Outer Diameter 5.5 mm | In distribution |
| 61065-25 | Length 25 mm | In distribution |
| 55665-60 | Length 60 mm | In distribution |
| 55505-120 | Outer Diameter 10.5 mm | In distribution |
| 55060-35 | Length 35 mm | In distribution |
| 55345-55 | Outer Diameter 4.5 mm | In distribution |
| 55505-55 | Length 55 mm | In distribution |
| R5506-045 | Length 45 mm | In distribution |
| 55075-45 | Outer Diameter 7.5 mm | In distribution |
| 55045-55 | Outer Diameter 4.5 mm | In distribution |
| 77545-60 | Length 60 mm | In distribution |
| R5505-040 | Outer Diameter 5.5 mm | In distribution |
| 55845-45 | Outer Diameter 4.5 mm | In distribution |
| 51065-30 | Length 30 mm | In distribution |
| 77605-70 | Outer Diameter 10.5 mm | In distribution |
| 55275-50 | Length 50 mm | In distribution |
| 55080-30 | Outer Diameter 8 mm | In distribution |
| 55405-70 | Length 70 mm | In distribution |
| 55070-25 | Length 25 mm | In distribution |
| 55050-60 | Length 60 mm | In distribution |
| R5509-070 | Outer Diameter 5.5 mm | In distribution |
| 55675-100 | Length 100 mm | In distribution |
| 55675-110 | Length 110 mm | In distribution |
| 55485-40 | Outer Diameter 8.5 mm | In distribution |
| 55855-45 | Outer Diameter 5.5 mm | In distribution |
| 55575-45 | Length 45 mm | In distribution |
| 55595-50 | Outer Diameter 9.5 mm | In distribution |
| 55575-30 | Outer Diameter 7.5 mm | In distribution |
| R5504-100 | Outer Diameter 5.5 mm | In distribution |
| 55585-60 | Length 60 mm | In distribution |
| 77365-60 | Length 60 mm | In distribution |
| 55345-35 | Outer Diameter 4.5 mm | In distribution |
| 55255-30 | Length 30 mm | In distribution |
| 55085-90 | Outer Diameter 8.5 mm | In distribution |
| 55300-60 | Length 60 mm | In distribution |
| 61210-01 | In distribution | |
| 77505-80 | Outer Diameter 10.5 mm | In distribution |
| R5509-055 | Outer Diameter 5.5 mm | In distribution |
| 55575-25 | Length 25 mm | In distribution |
| 51075-25 | Outer Diameter 7.5 mm | In distribution |
| 55045-55 | Outer Diameter 4.5 mm | In distribution |
| 55555-45 | Length 45 mm | In distribution |
| 77685-50 | Outer Diameter 8.5 mm | In distribution |
| 77585-70 | Length 70 mm | In distribution |
| 55445-45 | Length 45 mm | In distribution |
| 55245-50 | Length 50 mm | In distribution |
| 77595-45 | Outer Diameter 9.5 mm | In distribution |
| R55000-150 | Outer Diameter 5.5 mm | In distribution |
| 61185-50 | Outer Diameter 8.5 mm | In distribution |
| 55865-55 | Outer Diameter 6.5 mm | In distribution |
| 55675-70 | Length 70 mm | In distribution |
| R5505-045 | Length 45 mm | In distribution |
| 55455-45 | Length 45 mm | In distribution |
| 55595-120 | Length 120 mm | In distribution |
| 55455-50 | Length 50 mm | In distribution |
| 55875-110 | Length 110 mm | In distribution |
| 55095-70 | Length 70 mm | In distribution |
| 55345-50 | Outer Diameter 4.5 mm | In distribution |
| 55375-35 | Outer Diameter 7.5 mm | In distribution |
| 55555-50 | Outer Diameter 5.5 mm | In distribution |
| 55875-100 | Outer Diameter 7.5 mm | In distribution |
| R5507-075 | Length 75 mm | In distribution |
| 61075-55 | Length 55 mm | In distribution |
| 77665-25 | Length 25 mm | In distribution |
| 55075-35 | Outer Diameter 7.5 mm | In distribution |
| 55595-110 | Outer Diameter 9.5 mm | In distribution |
| R5508-070 | Outer Diameter 5.5 mm | In distribution |
| 55045-25 | Length 25.0 mm | In distribution |
| 55265-60 | Outer Diameter 6.5 mm | In distribution |
| 55495-100 | Outer Diameter 9.5 mm | In distribution |
| 55095-120 | Outer Diameter 9.5 mm | In distribution |
| 55195-110 | Length 110 mm | In distribution |
| 55055-55 | Outer Diameter 5.5 mm | In distribution |
| 60085-30 | Outer Diameter 8.5 mm | In distribution |
| 55050-50 | Outer Diameter 5 mm | In distribution |
| R5502-140 | Outer Diameter 5.5 mm | In distribution |
| R5502-100 | Outer Diameter 5.5 mm | In distribution |
| 55300-60 | Length 60.0 mm | In distribution |
| R5500-060 | Length 60 mm | In distribution |
| R55000-60 | Outer Diameter 5.5 mm | In distribution |
| 51075-30 | Length 30 mm | In distribution |
| R5505-060 | Length 60 mm | In distribution |
| 55585-100 | Length 100 mm | In distribution |
| 55045-40 | Length 40 mm | In distribution |
| 55505-50 | Length 50 mm | In distribution |
| 55085-70 | Length 70 mm | In distribution |
| 55445-40 | Length 40 mm | In distribution |
| 55205-100 | Outer Diameter 10.5 mm | In distribution |
| 77675-55 | Outer Diameter 7.5 mm | In distribution |
| 55485-120 | Length 120 mm | In distribution |
| 55675-25 | Outer Diameter 7.5 mm | In distribution |
| 55075-90 | Outer Diameter 7.5 mm | In distribution |
| 77855-55 | Outer Diameter 5.5 mm | In distribution |
| 55585-35 | Length 35 mm | In distribution |
| 77855-50 | Length 50 mm | In distribution |
| 55505-100 | Outer Diameter 10.5 mm | In distribution |
| 55445-30 | Length 30 mm | In distribution |
| 55405-55 | Outer Diameter 10.5 mm | In distribution |
| 55675-120 | Outer Diameter 7.5 mm | In distribution |
| R5504-040 | Outer Diameter 5.5 mm | In distribution |
| 55465-30 | Outer Diameter 6.5 mm | In distribution |
| 60155-40 | Outer Diameter 5.5 mm | In distribution |
| 55000-20 | 5.5 Millimeter 2nd Diameter | In distribution |
| 55575-100 | Length 100 mm | In distribution |
| 51065-35 | Length 35 mm | In distribution |
| 55205-100 | Length 100 mm | In distribution |
| R5509-035 | Outer Diameter 5.5 mm | In distribution |
| 55405-80 | Length 80 mm | In distribution |
| 77675-55 | Outer Diameter 7.5 mm | In distribution |
| 77575-90 | Length 90 mm | In distribution |
| 55195-120 | Outer Diameter 9.5 mm | In distribution |
| 51075-55 | Outer Diameter 7.5 mm | In distribution |
| 55300-15 | Length 15.0 mm | In distribution |
| 55055-45 | Outer Diameter 5.5 mm | In distribution |
| R5510-035 | Outer Diameter 5.5 mm | In distribution |
| 55485-55 | Outer Diameter 8.5 mm | In distribution |
| 55405-110 | Outer Diameter 10.5 mm | In distribution |
| 61175-60 | Length 60 mm | In distribution |
| 55075-110 | Length 110 mm | In distribution |
| 77875-90 | Length 90 mm | In distribution |
| 55465-40 | Outer Diameter 6.5 mm | In distribution |
| 60215-01 | In distribution | |
| 55565-45 | Outer Diameter 6.5 mm | In distribution |
| 55685-100 | Length 100 mm | In distribution |
| R5505-150 | Length 150 mm | In distribution |
| 55655-35 | Length 35 mm | In distribution |
| 55295-120 | Length 120 mm | In distribution |
| 60355-20 | In distribution | |
| 55080-45 | Length 45 mm | In distribution |
| R5508-040 | Length 40 mm | In distribution |
| 77605-50 | Length 50 mm | In distribution |
| 55495-35 | Length 35 mm | In distribution |
| 60185-25 | Outer Diameter 8.5 mm | In distribution |
| 60065-30 | Length 30 mm | In distribution |
| 60175-50 | Length 50 mm | In distribution |
| 55455-40 | Length 40 mm | In distribution |
| 77555-55 | Length 55 mm | In distribution |
| 55605-120 | Length 120 mm | In distribution |
| 55045-50 | Length 50 mm | In distribution |
| 55095-90 | Outer Diameter 9.5 mm | In distribution |
| R5502-080 | Outer Diameter 5.5 mm | In distribution |
| R5507-120 | Length 120 mm | In distribution |
| 55475-50 | Length 50 mm | In distribution |
| 55685-80 | Length 80 mm | In distribution |
| R5507-065 | Length 65 mm | In distribution |
| R5503-100 | Outer Diameter 5.5 mm | In distribution |
| 61220-00 | In distribution | |
| 51065-45 | Length 45 mm | In distribution |
| 55685-110 | Outer Diameter 8.5 mm | In distribution |
| 61225-00 | In distribution | |
| 77875-45 | Length 45 mm | In distribution |
| 55585-50 | Length 50 mm | In distribution |
| 55605-45 | Length 45 mm | In distribution |
| 55855-55 | Outer Diameter 5.5 mm | In distribution |
| 55080-55 | Length 55 mm | In distribution |
| 55845-45 | Length 45 mm | In distribution |
| 55495-45 | Outer Diameter 9.5 mm | In distribution |
| 51075-35 | Outer Diameter 7.5 mm | In distribution |
| 55855-40 | Outer Diameter 5.5 mm | In distribution |
| 61175-45 | Outer Diameter 7.5 mm | In distribution |
| 55605-70 | Length 70 mm | In distribution |
| R55000-40 | Outer Diameter 5.5 mm | In distribution |
| 61065-80 | Outer Diameter 6.5 mm | In distribution |
| 55075-55 | Outer Diameter 7.5 mm | In distribution |
| 55065-55 | Length 55 mm | In distribution |
| R5505-095 | Length 95 mm | In distribution |
| 61055-60 | Length 60 mm | In distribution |
| 55001-4 | Narrow | In distribution |
| 55075-60 | Length 60 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K110321 | 2011-05-25 |
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.