OsteoMed
PrimaLOK SP 14mm Distractor Screws, Sterile 2-pack
11manufacturers in China registered for this device type
33catalogue 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 | Osteomed, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-05-22 |
| Record revised | 2024-02-19 (version 4) |
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 |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 59 to 86 °F |
| Sizes | Height 4 to 18 mm; length 25 to 68 mm |
| Distribution end date | 2017-12-29 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 800-0112 | Height 12 mm | Withdrawn |
| 800-0308 | Withdrawn | |
| 800-0315 | Withdrawn | |
| 800-0312 | Withdrawn | |
| 800-0106-SP | Height 6 mm | Withdrawn |
| 800-0239 | Withdrawn | |
| 800-0219 | Withdrawn | |
| 800-0130-10 | Length 30 mm | Withdrawn |
| 800-0110-SP | Height 10 mm | Withdrawn |
| 800-0108 | Height 8 mm | Withdrawn |
| 800-0318 | Withdrawn | |
| 800-0112-SP | Height 12 mm | Withdrawn |
| 800-0106 | Height 6 mm | Withdrawn |
| 800-0118-SP | Height 18 mm | Withdrawn |
| 800-0110 | Height 10 mm | Withdrawn |
| 800-0104-SP | Height 4 mm | Withdrawn |
| 800-0304 | Withdrawn | |
| 800-0310 | Withdrawn | |
| 800-0135-SP | Length 35 mm | Withdrawn |
| 800-0206-SP | Length 68 mm | Withdrawn |
| 800-0125-10 | Length 25 mm | Withdrawn |
| 800-0306 | Withdrawn | |
| 800-0104 | Height 4 mm | Withdrawn |
| 800-0828-SP | Grip Distance = 28mm | Withdrawn |
| 800-0125-SP | Length 25 mm | Withdrawn |
| 800-0130-SP | Length 30 mm | Withdrawn |
| 800-0135-10 | Length 39 mm | Withdrawn |
| 800-0221 | Withdrawn | |
| 800-0118 | Height 18 mm | Withdrawn |
| 800-0115 | Height 15 mm | Withdrawn |
| 800-0206 | Length 68 mm | Withdrawn |
| 800-0115-SP | Height 15 mm | Withdrawn |
| 800-0108-SP | Height 8 mm | Withdrawn |
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.