ReLine
RELINE-O Conn, 5-6/5-6mm 4H Parallel Med
2manufacturers in China registered for this device type
321catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Nuvasive, Inc., United States |
|---|---|
| FDA product code | PML |
| Device type | Bone Cement, Posterior Screw Augmentation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3027 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K180498 |
| Record published | 2021-02-25 |
| Record revised | 2025-06-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
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Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| M.u.s.t. Pedicle Screw System | Medacta International SA | 248 |
| CarboClear Hybrid Pedicle Screw System | CarboFix Orthopedics, Ltd. | 153 |
| Viper | Medos International Sàrl | 32 |
| Expedium Verse | Medos International Sàrl | 26 |
| CarboClear X Pedicle Screw System | CarboFix Orthopedics, Ltd. | 18 |
| Vader Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 5.5 x 55 mm | Icotec AG | 13 |
| CarboClear Modular Hybrid Pedicle Screw System | CarboFix Orthopedics, Ltd. | 11 |
| CarboClear Pedicle Screw System | CarboFix Orthopedics, Ltd. | 9 |
| icotec Pedicle System, Screw, Ti, Polyax., Fen., Ø 8.5 x 45 mm | Icotec AG | 6 |
| Vader Pedicle System, K-wire Dispenser, Extra Long, Ø 1.6 x 600 mm, Ø 1.1 x 600 | Icotec AG | 1 |
| Romeo® 2 | Spineart SA | 1 |
| Vader Pedicle System, K-wire, Nitinol, Ø 1.1 x 600 mm | Icotec AG | 1 |
Showing 12 of 14. All products under Bone Cement, Posterior Screw Augmentation
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.