F1 MPS Modular Pedicle Screw System
Connect-L Transverse Connector, Variable, Size 32-39
13manufacturers in China registered for this device type
126catalogue numbers in this listing
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, Spinal Pedicle Fixation
Record
| Listed by | Degen Medical, United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K142531 |
| Record published | 2016-09-09 |
| Record revised | 2025-07-02 (version 4) |
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 |
| Sizes | Length 26 to 200 mm; outer diameter 5 to 10 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0110-55050 | Outer Diameter 5.5 mm | In distribution |
| 0110-85065 | Outer Diameter 8.5 mm | In distribution |
| 0110-95080 | Outer Diameter 9.5 mm | In distribution |
| 0122-55035 | Outer Diameter 5.5 mm | In distribution |
| 0110-75085 | Outer Diameter 7.5 mm | In distribution |
| 0114-55040 | Outer Diameter 5.5 mm | In distribution |
| 0104-55200 | Length 200 mm | In distribution |
| 0110-80040 | Length 40 mm | In distribution |
| 0110-80050 | Outer Diameter 8 mm | In distribution |
| 0110-65050 | Length 50 mm | In distribution |
| 0117-80070 | Length 70 mm | In distribution |
| 0115-55075 | Outer Diameter 5.5 mm | In distribution |
| 0114-85070 | Length 70 mm | In distribution |
| 0115-50050 | Outer Diameter 5.5 mm | In distribution |
| 0119-5526F | Length 26 mm | In distribution |
| 0117-65080 | Outer Diameter 6.5 mm | In distribution |
| 0106-55030 | Outer Diameter 5.5 mm | In distribution |
| 0122-55200 | Length 200 mm | In distribution |
| 0117-85085 | Length 85 mm | In distribution |
| 0107-55090 | Outer Diameter 5.5 mm | In distribution |
| 0102-10090 | Length 90 mm | In distribution |
| 0110-80075 | Outer Diameter 8 mm | In distribution |
| 0122-55050 | Length 50 mm | In distribution |
| 0110-60055 | Length 55 mm | In distribution |
| 0115-50030 | Outer Diameter 5.5 mm | In distribution |
| 0117-95095 | Length 95 mm | In distribution |
| 0122-55060 | Outer Diameter 5.5 mm | In distribution |
| 0114-75070 | Length 70 mm | In distribution |
| 0102-55055 | Outer Diameter 5.5 mm | In distribution |
| 0117-95040 | Length 40 mm | In distribution |
| 0106-55080 | Length 80 mm | In distribution |
| 0110-55060 | Length 60 mm | In distribution |
| 0104-55055 | Outer Diameter 5.5 mm | In distribution |
| 0110-70080 | Outer Diameter 7 mm | In distribution |
| 0104-55045 | Length 45 mm | In distribution |
| 0114-70070 | Length 70 mm | In distribution |
| 0102-50045 | Length 45 mm | In distribution |
| 0117-65050 | Length 50 mm | In distribution |
| 0114-95030 | Length 30 mm | In distribution |
| 0117-75090 | Outer Diameter 7.5 mm | In distribution |
| 0110-10030 | Outer Diameter 10 mm | In distribution |
| 0116-55070 | Length 70 mm | In distribution |
| 0110-50060 | Length 60 mm | In distribution |
| 0110-90030 | Outer Diameter 9 mm | In distribution |
| 0114-85060 | Outer Diameter 8.5 mm | In distribution |
| 0114-10065 | Outer Diameter 10 mm | In distribution |
| 0102-90065 | Outer Diameter 9 mm | In distribution |
| 0114-50060 | Length 60 mm | In distribution |
| 0104-55090 | Length 90 mm | In distribution |
| 0110-90080 | Length 80 mm | In distribution |
| 0117-55035 | Outer Diameter 5.5 mm | In distribution |
| 0114-10080 | Length 80 mm | In distribution |
| 0106-55040 | Outer Diameter 5.5 mm | In distribution |
| 0110-65090 | Length 90 mm | In distribution |
| 0106-55150 | Length 150 mm | In distribution |
| 0114-55060 | Outer Diameter 5.5 mm | In distribution |
| 0106-55140 | Length 140 mm | In distribution |
| 0117-50050 | Length 50 mm | In distribution |
| 0117-95085 | Outer Diameter 9.5 mm | In distribution |
| 0121-55040 | Length 40 mm | In distribution |
| 0115-50060 | Length 60 mm | In distribution |
| 0114-95040 | Length 40 mm | In distribution |
| 0102-90075 | Outer Diameter 9 mm | In distribution |
| 0110-85045 | Length 45 mm | In distribution |
| 0114-80095 | Length 95 mm | In distribution |
| 0102-95060 | Outer Diameter 9.5 mm | In distribution |
| 0117-80050 | Length 50 mm | In distribution |
| 0114-80050 | Outer Diameter 8 mm | In distribution |
| 0110-50035 | Length 35 mm | In distribution |
| 0110-70035 | Length 35 mm | In distribution |
| 0110-10060 | Length 60 mm | In distribution |
| 0114-50040 | Outer Diameter 5 mm | In distribution |
| 0107-55040 | Length 40 mm | In distribution |
| 0122-55065 | Length 65 mm | In distribution |
| 0106-55160 | Length 160 mm | In distribution |
| 0117-90090 | Outer Diameter 9 mm | In distribution |
| 0110-90040 | Outer Diameter 9 mm | In distribution |
| 0117-60040 | Length 40 mm | In distribution |
| 0102-70030 | Length 30 mm | In distribution |
| 0106-55190 | Outer Diameter 5.5 mm | In distribution |
| 0114-80035 | Length 35 mm | In distribution |
| 0115-50045 | Outer Diameter 5.5 mm | In distribution |
| 0102-75085 | Outer Diameter 7.5 mm | In distribution |
| 0115-55100 | Outer Diameter 5.5 mm | In distribution |
| 0102-70035 | Length 35 mm | In distribution |
| 0102-10075 | Length 75 mm | In distribution |
| 0117-75070 | Length 70 mm | In distribution |
| 0105-55080 | Outer Diameter 5.5 mm | In distribution |
| 0110-90075 | Outer Diameter 9 mm | In distribution |
| 0114-10070 | Outer Diameter 10 mm | In distribution |
| 0122-55110 | Length 110 mm | In distribution |
| 0102-85090 | Length 90 mm | In distribution |
| 0114-65030 | Outer Diameter 6.5 mm | In distribution |
| 0102-90055 | Outer Diameter 9 mm | In distribution |
| 0110-10075 | Length 75 mm | In distribution |
| 0102-55035 | Outer Diameter 5.5 mm | In distribution |
| 0114-80085 | Outer Diameter 8 mm | In distribution |
| 0114-75080 | Length 80 mm | In distribution |
| 0121-55050 | Length 50 mm | In distribution |
| 0102-70065 | Length 65 mm | In distribution |
| 0104-55035 | Outer Diameter 5.5 mm | In distribution |
| 0110-90095 | Outer Diameter 9 mm | In distribution |
| 0114-85065 | Length 65 mm | In distribution |
| 0117-65030 | Length 30 mm | In distribution |
| 0102-80085 | Length 85 mm | In distribution |
| 0114-75030 | Outer Diameter 7.5 mm | In distribution |
| 0117-70090 | Length 90 mm | In distribution |
| 0117-80030 | Length 30 mm | In distribution |
| 0122-55130 | Outer Diameter 5.5 mm | In distribution |
| 0118-3207V | In distribution | |
| 0121-55110 | Length 110 mm | In distribution |
| 0110-95055 | Outer Diameter 9.5 mm | In distribution |
| 0102-95085 | Outer Diameter 9.5 mm | In distribution |
| 0117-50055 | Outer Diameter 5 mm | In distribution |
| 0102-90090 | Length 90 mm | In distribution |
| 0102-70095 | Length 95 mm | In distribution |
| 0102-95035 | Length 35 mm | In distribution |
| 0114-80090 | Outer Diameter 8 mm | In distribution |
| 0114-95085 | Length 85 mm | In distribution |
| 0102-90070 | Outer Diameter 9 mm | In distribution |
| 0102-55060 | Length 60 mm | In distribution |
| 0110-60060 | Outer Diameter 6 mm | In distribution |
| 0117-65035 | Length 35 mm | In distribution |
| 0107-55070 | Outer Diameter 5.5 mm | In distribution |
| 0114-70055 | Length 55 mm | In distribution |
| 0121-55075 | Length 75 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
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.