Romeo Posterior Osteosynthesis System
Titanium longitudinal rod with hexa tip
11manufacturers in China registered for this device type
385catalogue numbers in this listing
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 | Spineart SA, Switzerland |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2018-12-28 |
| Record revised | 2025-03-31 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Pack of 2 |
| Sizes | Length 18 to 550 mm; outer diameter 3.6 to 8 mm; width 150 to 230 mm; length 30 µm; outer diameter 7 cm; height 25 mm |
| Distribution end date | 2018-04-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ELL-CC MU 36-N | Length 43 mm | In distribution |
| MIS-TS 55 30-N | Outer Diameter 5.5 mm | In distribution |
| ELL-TR 00 40-N | Length 40 mm | In distribution |
| MIS-RT 10 75-S | Outer Diameter 5.4 mm | In distribution |
| ELL-MS 06 80-S | In distribution | |
| MIS-PS 06 40-N | Length 40 mm | In distribution |
| ELL-RD 30 55-N | Length 55 mm | In distribution |
| ELL-DS 45 40-N | Outer Diameter 4.5 mm | In distribution |
| MIS-RT 00 35-S | Outer Diameter 5.4 mm | In distribution |
| MIS-RT 11 30-S | Outer Diameter 5.4 mm | In distribution |
| ELL-MS 07 35-N | Outer Diameter 7 mm | In distribution |
| ELL-HO LL EX-N | In distribution | |
| ELL-RD 03 50-N | Outer Diameter 5.4 mm | In distribution |
| ELL-MS 06 80-N | Outer Diameter 6 mm | In distribution |
| ELL-SS 08 80-S | Length 80 mm | In distribution |
| ELL-DS 04 25-N | Outer Diameter 4 mm | In distribution |
| ELL-MS 06 50-N | Outer Diameter 6 mm | In distribution |
| ELL-RD 21 60-N | Length 160 mm | In distribution |
| ELL-RD 30 45-S | Length 45 mm | In distribution |
| MIS-RT 01 20-S | Outer Diameter 5.4 mm | In distribution |
| ELL-DS 55 50-N | Outer Diameter 5.5 mm | In distribution |
| MIS-PS 55 55-N | Length 55 mm | In distribution |
| MIS-RT 11 90-N | Width 180 mm | In distribution |
| ELL-RD 12 40-N | Outer Diameter 5.4 mm | In distribution |
| ELL-DS 45 30-N | Outer Diameter 4.5 mm | In distribution |
| ELL-MS 55 40-S | Length 40 mm | In distribution |
| ELL-MS 07 70-N | Outer Diameter 7 mm | In distribution |
| MIS-RT 12 40-N | Width 230 mm | In distribution |
| ELL-PS 45 40-S | Length 40 mm | In distribution |
| MIS-TS 07 55-S | Outer Diameter 07 mm | In distribution |
| MIS-PS 06 45-S | Outer Diameter 06 mm | In distribution |
| MIS-RT 00 55-S | Outer Diameter 5.4 mm | In distribution |
| MIS-RT 11 60-N | Length 160 mm | In distribution |
| ELL-PS 55 60-S | Length 60 mm | In distribution |
| MIS-RT 10 30-S | Outer Diameter 5.4 mm | In distribution |
| MIS-RT 00 60-S | Outer Diameter 5.4 mm | In distribution |
| MIS-RT 10 85-S | Outer Diameter 5.4 mm | In distribution |
| MIS-PS 06 50-N | Length 50 mm | In distribution |
| ELL-MS 04 25-S | Length 25 mm | In distribution |
| ELL-MS 07 45-N | Outer Diameter 7 mm | In distribution |
| MIS-PS 55 45-N | Length 45 mm | In distribution |
| ELL-RD 30 40-S | Length 40 mm | In distribution |
| MIS-RT 10 65-S | Outer Diameter 5.4 mm | In distribution |
| ELL-MS 45 30-S | Length 30 mm | In distribution |
| ELL-MS 08 55-S | Length 55 mm | In distribution |
| MIS-RT 00 40-S | Outer Diameter 5.4 mm | In distribution |
| MIS-RT 11 40-S | Outer Diameter 5.4 mm | In distribution |
| ELL-PS 04 35-S | Length 35 mm | In distribution |
| ELL-CC ST 18-N | Length 18 mm | In distribution |
| ELL-CC ST 30-N | Length 30 mm | In distribution |
| ELL-RC PA 00-S | In distribution | |
| MIS-TS 05 50-S | Outer Diameter 05 mm | In distribution |
| ELL-RD 02 20-N | Outer Diameter 5.4 mm | In distribution |
| MIS-RT 00 90-N | Length 90 mm | In distribution |
| MIS-RT 10 70-S | Outer Diameter 5.4 mm | In distribution |
| MIS-PS 07 35-N | Length 35 mm | In distribution |
| MIS-TS 06 50-S | Outer Diameter 06 mm | In distribution |
| MIS-RT 02 50-S | Outer Diameter 5.4 mm | In distribution |
| ELL-RD 40 60-S | Length 60 mm | In distribution |
| MIS-TS 06 55-S | Outer Diameter 06 mm | In distribution |
| ELL-PS 45 45-S | Length 45 mm | In distribution |
| ELL-HO LL 0L-N | In distribution | |
| MIS-RT 11 50-N | Width 150 mm | In distribution |
| ELL-SS 04 30-S | Length 30 mm | In distribution |
| ELL-MS 06 30-N | Outer Diameter 6 mm | In distribution |
| ELL-DS 07 35-N | Outer Diameter 7 mm | In distribution |
| MIS-RT 10 80-S | Outer Diameter 5.4 mm | In distribution |
| MIS-RT 00 70-S | Outer Diameter 5.4 mm | In distribution |
| MIS-TS 55 40-N | Outer Diameter 5.5 mm | In distribution |
| MIS-RT 01 50-N | Length 150 mm | In distribution |
| MIS-RT 00 90-S | Outer Diameter 5.4 mm | In distribution |
| MIS-TS 07 35-N | Outer Diameter 7 mm | In distribution |
| ELL-MS 08 45-S | Length 45 mm | In distribution |
| MIS-PS 07 40-S | Outer Diameter 07 mm | In distribution |
| MIS-RT 01 00-S | Outer Diameter 5.4 mm | In distribution |
| ELL-MS 45 25-S | Length 25 mm | In distribution |
| ELL-MS 45 40-N | Length 40 mm | In distribution |
| MIS-RT 00 50-S | Outer Diameter 5.4 mm | In distribution |
| MIS-PS 55 50-S | Outer Diameter 5.5 mm | In distribution |
| ELL-MS 08 60-S | Length 60 mm | In distribution |
| MIS-RT 11 90-S | Outer Diameter 5.4 mm | In distribution |
| MIS-RT 10 80-N | Length 80 mm | In distribution |
| ELL-RD 10 40-S | Length 40 mm | In distribution |
| ELL-RD 22 20-S | Length 220 mm | In distribution |
| MIS-RT 00 70-N | Length 70 mm | In distribution |
| ELL-PS 05 50-S | Length 50 mm | In distribution |
| MIS-RT 01 60-N | Length 160 mm | In distribution |
| ELL-RD 11 40-S | Length 140 mm | In distribution |
| ELL-HO OF 0L-N | In distribution | |
| ELL-MS 08 30-S | Length 30 mm | In distribution |
| ELL-MS 05 35-N | Length 35 mm | In distribution |
| ELL-MS 08 40-N | Outer Diameter 8 mm | In distribution |
| ELL-NV 05 00-N | In distribution | |
| ELL-PS 08 11-S | Length 110 mm | In distribution |
| ELL-PS 08 12-S | Length 120 mm | In distribution |
| ELL-IC 01 40-S | Length 40 mm | In distribution |
| ELL-RD 10 35-S | Length 35 mm | In distribution |
| MIS-RT 11 80-S | Outer Diameter 5.4 mm | In distribution |
| ELL-RD 12 00-N | Outer Diameter 5.4 mm | In distribution |
| ELL-RD 00 55-S | Length 55 mm | In distribution |
| MIS-PS 07 45-N | Length 45 mm | In distribution |
| MIS-TS 05 45-S | Outer Diameter 05 mm | In distribution |
| MIS-PS 06 55-S | Outer Diameter 06 mm | In distribution |
| ELL-MS 05 35-S | Length 35 mm | In distribution |
| ELL-DS 55 35-N | Outer Diameter 5.5 mm | In distribution |
| MIS-TS 55 60-N | Outer Diameter 5.5 mm | In distribution |
| ELL-PS 08 55-S | Length 55 mm | In distribution |
| ELL-PS 06 60-S | Length 60 mm | In distribution |
| MIS-RT 10 55-S | Outer Diameter 5.4 mm | In distribution |
| ELL-PS 08 40-S | Length 40 mm | In distribution |
| ELL-MS 55 40-N | Outer Diameter 5.5 mm | In distribution |
| MIS-TS 55 60-S | Outer Diameter 5.5 mm | In distribution |
| ELL-DS 06 35-N | Outer Diameter 6 mm | In distribution |
| MIS-TS 05 35-S | Outer Diameter 5 mm | In distribution |
| ELL-PS 07 80-S | Length 80 mm | In distribution |
| ELL-RD 11 20-N | Outer Diameter 5.4 mm | In distribution |
| ELL-RD 21 40-S | Length 140 mm | In distribution |
| ELL-RD 30 60-N | Length 60 mm | In distribution |
| ELL-RD 15 50-S | Outer Diameter 5.4 mm | In distribution |
| MIS-TS 07 50-S | Outer Diameter 07 mm | In distribution |
| MIS-RT 01 50-S | Outer Diameter 5.4 mm | In distribution |
| ELL-DS 04 45-N | Outer Diameter 4 mm | In distribution |
| ELL-RD 40 45-S | Length 40 mm | In distribution |
| ELL-RD 40 90-N | Length 90 mm | In distribution |
| ELL-HO LT SU-N | In distribution | |
| ELL-PS 55 55-N | Length 50 mm | In distribution |
| ELL-RD 10 45-S | Length 45 mm | In distribution |
| ELL-CC MU 31-N | Length 33 mm | In distribution |
| MIS-TS 06 45-N | Outer Diameter 6 mm | In distribution |
| MIS-RT 11 50-S | Outer Diameter 5.4 mm | In distribution |
| ELL-SC 00 00-N | Outer Diameter 3.6 mm | In distribution |
| ELL-TR 00 20-N | Length 20 mm | In distribution |
| ELL-RD 10 80-S | Length 80 mm | In distribution |
| MIS-RT 01 90-N | Length 190 mm | In distribution |
| ELL-MS 06 70-S | Length 70 mm | In distribution |
| ELL-DS 07 45-N | Outer Diameter 7 mm | In distribution |
| ELL-SS 07 80-S | Length 80 mm | In distribution |
| MIS-RT 11 30-N | Length 130 mm | In distribution |
| MIS-PS 07 60-S | Outer Diameter 07 mm | In distribution |
| MIS-RT 00 65-S | Outer Diameter 5.4 mm | In distribution |
| ELL-MS 05 30-S | Length 30 mm | In distribution |
| MIS-TS 07 55-N | Outer Diameter 7 mm | In distribution |
| MIS-PS 06 60-S | Outer Diameter 06 mm | In distribution |
| ELL-SS 08 30-S | Length 30 mm | In distribution |
| MIS-TS 55 30-S | Outer Diameter 5.5 mm | In distribution |
| ELL-RD 11 00-S | Length 100 mm | In distribution |
| ELL-RD 15 00-S | Length 500 mm | In distribution |
| MIS-RT 01 30-S | Outer Diameter 5.4 mm | In distribution |
| MIS-RT 10 90-N | Length 90 mm | In distribution |
| ELL-PS 08 50-S | Length 50 mm | In distribution |
| ELL-MS 04 25-N | Length 25 mm | In distribution |
| ELL-MS 45 45-S | In distribution | |
| ELL-HO AN 0L-N | In distribution | |
| MIS-TS 55 40-S | Outer Diameter 5.5 mm | In distribution |
| MIS-TS 06 35-N | Outer Diameter 6 mm | In distribution |
| ELL-RD 12 00-S | Length 200 mm | In distribution |
| ELL-SS 04 40-S | Length 40 mm | In distribution |
| MIS-RT 01 10-S | Outer Diameter 5.4 mm | In distribution |
| ELL-PS 08 90-S | Length 90 mm | In distribution |
| ELL-MS 06 60-N | Outer Diameter 6 mm | In distribution |
| MIS-TS 55 50-N | Outer Diameter 5.5 mm | In distribution |
| ELL-RD 40 70-N | Length 70 mm | In distribution |
| MIS-TS 06 40-S | Outer Diameter 06 mm | In distribution |
| ELL-SS 08 40-S | Length 40 mm | In distribution |
| ELL-RD 10 50-S | Length 50 mm | In distribution |
| ELL-DS 05 50-N | Outer Diameter 5 mm | In distribution |
| MIS-RT 11 20-S | Outer Diameter 5.4 mm | In distribution |
| ELL-MS 08 50-S | Length 50 mm | In distribution |
| ELL-MS 04 30-S | Length 30 µm | In distribution |
| ELL-MS 08 35-S | Length 35 mm | In distribution |
| ELL-DS 06 70-N | Outer Diameter 6 mm | In distribution |
| ELL-SS 06 25-S | Length 25 mm | In distribution |
| ELL-RD 22 20-N | Outer Diameter 5.4 mm | In distribution |
| ELL-MS 55 30-N | Length 30 mm | In distribution |
| MIS-TS 55 45-S | Outer Diameter 5.5 mm | In distribution |
| ELL-RD 21 80-S | Length 180 mm | In distribution |
| MIS-RT 00 80-S | Outer Diameter 5.4 mm | In distribution |
| ELL-IC 00 60-N | Length 60 mm | In distribution |
| MIS-RT 01 80-S | Outer Diameter 5.4 mm | In distribution |
| MIS-RT 02 00-S | Outer Diameter 5.4 mm | In distribution |
| ELL-RD 10 90-S | Length 90 mm | In distribution |
| ELL-RC PA 00-N | In distribution | |
| ELL-RD 40 40-N | Length 40 mm | In distribution |
| ELL-PS 04 30-S | Length 30 mm | In distribution |
| MIS-RT 02 20-N | Length 220 mm | In distribution |
| MIS-RT 12 40-S | Outer Diameter 5.4 mm | In distribution |
| MIS-PS 55 45-S | Outer Diameter 5.5 mm | In distribution |
| ELL-SS 08 60-S | Length 60 mm | In distribution |
| MIS-RT 10 40-N | Length 40 mm | In distribution |
| ELL-DS 05 40-N | Outer Diameter 5 mm | In distribution |
| ELL-DS 04 35-N | Outer Diameter 4 mm | In distribution |
| ELL-RD 30 80-N | Length 80 mm | In distribution |
| ELL-MS 05 25-S | Length 25 mm | In distribution |
| ELL-PS 08 60-S | Length 60 mm | In distribution |
| ELL-PS 08 35-S | Length 35 mm | In distribution |
| ELL-RD 40 30-N | Length 30 mm | In distribution |
| MIS-RT 00 30-S | Outer Diameter 5.4 mm | In distribution |
| ELL-RD 25 50-S | Length 550 mm | In distribution |
| ELL-PS 04 45-S | Length 45 mm | In distribution |
| MIS-RT 11 00-S | Outer Diameter 5.4 mm | In distribution |
| ELL-MS 55 45-S | Length 45 mm | In distribution |
| ELL-PS 45 35-S | Length 35 mm | In distribution |
| ELL-IC 01 60-S | Length 60 mm | In distribution |
| ELL-RD 11 20-S | Length 100 mm | In distribution |
| MIS-TS 05 40-S | Outer Diameter 5 mm | In distribution |
| ELL-RD 22 00-S | Length 200 mm | In distribution |
| ELL-PS 45 25-S | Length 25 mm | In distribution |
| ELL-RD 10 60-S | Length 60 mm | In distribution |
| MIS-RT 01 70-S | Outer Diameter 5.4 mm | In distribution |
| ELL-PS 45 30-S | Length 30 mm | In distribution |
| MIS-PS 06 35-S | Outer Diameter 06 mm | In distribution |
| MIS-RT 00 50-N | Length 50 mm | In distribution |
| MIS-TS 06 30-S | Outer Diameter 06 mm | In distribution |
| ELL-PS 06 80-S | Length 80 mm | In distribution |
| MIS-RT 10 35-S | Outer Diameter 5.4 mm | In distribution |
| ELL-CC ST 24-N | Length 24 mm | In distribution |
| MIS-NV 02 00-N | In distribution | |
| MIS-PS 06 60-N | Length 60 mm | In distribution |
| MIS-RT 12 20-S | Outer Diameter 5.4 mm | In distribution |
| ELL-MS 45 30-N | Length 30 mm | In distribution |
| MIS-PS 55 60-S | Outer Diameter 5.5 mm | In distribution |
| ELL-RD 30 35-S | Length 35 mm | In distribution |
| ELL-RD 40 50-N | Length 50 mm | In distribution |
| ELL-RD 40 35-S | Length 35 mm | In distribution |
| MIS-RT 10 40-S | Outer Diameter 5.4 mm | In distribution |
| ELL-RD 12 40-S | Length 240 mm | In distribution |
| ELL-DS 07 55-N | Outer Diameter 7 mm | In distribution |
| MIS-RT 00 45-S | Outer Diameter 5.4 mm | In distribution |
| ELL-DS 05 30-N | Outer Diameter 5 mm | In distribution |
| ELL-DS 07 90-N | Outer Diameter 7 mm | In distribution |
| ELL-PS 07 60-S | In distribution | |
| ELL-RD 00 45-S | Length 45 mm | In distribution |
| MIS-RT 12 00-S | Outer Diameter 5.4 mm | In distribution |
| MIS-RT 01 40-S | Outer Diameter 5.4 mm | In distribution |
| ELL-TR 00 60-N | Outer Diameter 3.6 mm | In distribution |
| MIS-RT 11 20-N | Length 120 mm | In distribution |
| SPE-IN 01 71-N | In distribution | |
| MIS-TS 55 35-S | Outer Diameter 5.5 mm | In distribution |
| MIS-TS 05 35-N | Outer Diameter 5 mm | In distribution |
| MIS-RT 01 10-N | Length 110 mm | In distribution |
| ELL-PS 55 30-S | Length 30 mm | In distribution |
| MIS-TS 06 35-S | Outer Diameter 06 mm | In distribution |
| MIS-RT 02 40-S | Outer Diameter 5.4 mm | In distribution |
| ELL-PS 08 30-S | Length 30 mm | In distribution |
| ELL-RD 30 70-S | Length 70 mm | In distribution |
| MIS-PS 06 50-S | Outer Diameter 06 mm | In distribution |
| MIS-TS 07 40-S | Outer Diameter 07 mm | In distribution |
| MIS-PS 07 55-N | Length 55 mm | In distribution |
| MIS-TS 07 45-N | Outer Diameter 7 mm | In distribution |
| MIS-RT 00 75-S | Outer Diameter 5.4 mm | In distribution |
Showing 250 of 300 catalogue numbers.
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
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.