F1 MPS Modular Pedicle Screw System
Polyaxial Cannulated Screw, CoCr, 10.0mm X 40mm
7manufacturers in China registered for this device type
204catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shandong (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Degen Medical, United States |
|---|---|
| FDA product code | OSH |
| Device type | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K142531 |
| Record published | 2016-09-13 |
| 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 30 to 500 mm; outer diameter 5 to 10 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0114-75095 | Length 95 mm | In distribution |
| 0122-55300 | Length 300 mm | In distribution |
| 0116-55120 | Length 120 mm | In distribution |
| 0108-0816M | In distribution | |
| 0116-55500 | Outer Diameter 5.5 mm | In distribution |
| 0114-65085 | Outer Diameter 6.5 mm | In distribution |
| 0117-95030 | Outer Diameter 9.5 mm | In distribution |
| 0110-80095 | Outer Diameter 8 mm | In distribution |
| 0102-70045 | Length 45 mm | In distribution |
| 0114-65060 | Outer Diameter 6.5 mm | In distribution |
| 0105-55045 | Length 45 mm | In distribution |
| 0117-65065 | Length 65 mm | In distribution |
| 0122-55090 | Outer Diameter 5.5 mm | In distribution |
| 0102-75070 | Outer Diameter 7.5 mm | In distribution |
| 0110-65030 | Outer Diameter 6.5 mm | In distribution |
| 0117-70050 | Outer Diameter 7 mm | In distribution |
| 0107-55050 | Length 50 mm | In distribution |
| 0114-60060 | Outer Diameter 6 mm | In distribution |
| 0102-85070 | Length 70 mm | In distribution |
| 0102-55050 | Length 50 mm | In distribution |
| 0110-90055 | Outer Diameter 9 mm | In distribution |
| 0102-75040 | Length 40 mm | In distribution |
| 0110-65085 | Outer Diameter 6.5 mm | In distribution |
| 0102-80055 | Length 55 mm | In distribution |
| 0102-65095 | Length 95 mm | In distribution |
| 0117-65095 | Length 95 mm | In distribution |
| 0110-50030 | Length 30 mm | In distribution |
| 0114-75085 | Outer Diameter 7.5 mm | In distribution |
| 0110-85040 | Length 40 mm | In distribution |
| 0110-55040 | Outer Diameter 5.5 mm | In distribution |
| 0102-65055 | Outer Diameter 6.5 mm | In distribution |
| 0114-55055 | Length 55 mm | In distribution |
| 0114-90080 | Length 80 mm | In distribution |
| 0116-50040 | Length 40 mm | In distribution |
| 0117-10040 | Outer Diameter 10 mm | In distribution |
| 0105-55050 | Outer Diameter 5.5 mm | In distribution |
| 0117-90065 | Outer Diameter 9 mm | In distribution |
| 0102-75065 | Outer Diameter 7.5 mm | In distribution |
| 0117-85035 | Outer Diameter 8.5 mm | In distribution |
| 0110-75065 | Length 65 mm | In distribution |
| 0102-85095 | Outer Diameter 8.5 mm | In distribution |
| 0102-85030 | Outer Diameter 8.5 mm | In distribution |
| 0110-65065 | Length 65 mm | In distribution |
| 0106-55060 | Length 60 mm | In distribution |
| 0114-85095 | Outer Diameter 8.5 mm | In distribution |
| 0110-90085 | Length 85 mm | In distribution |
| 0115-50055 | Outer Diameter 5.5 mm | In distribution |
| 0117-70080 | Length 80 mm | In distribution |
| 0102-75095 | Outer Diameter 7.5 mm | In distribution |
| 0114-10055 | Outer Diameter 10 mm | In distribution |
| 0117-65060 | Length 60 mm | In distribution |
| 0116-50035 | Length 35 mm | In distribution |
| 0117-10050 | Outer Diameter 10 mm | In distribution |
| 0122-55170 | Length 170 mm | In distribution |
| 0114-75060 | Length 60 mm | In distribution |
| 0117-65085 | Length 85 mm | In distribution |
| 0114-60055 | Outer Diameter 6 mm | In distribution |
| 0117-80035 | Length 35 mm | In distribution |
| 0117-50030 | Outer Diameter 5 mm | In distribution |
| 0117-80075 | Outer Diameter 8 mm | In distribution |
| 0117-10045 | Outer Diameter 10 mm | In distribution |
| 0114-85085 | Length 85 mm | In distribution |
| 0110-75070 | Outer Diameter 7.5 mm | In distribution |
| 0114-65045 | Outer Diameter 6.5 mm | In distribution |
| 0117-80055 | Outer Diameter 8 mm | In distribution |
| 0114-75065 | Length 65 mm | In distribution |
| 0110-80090 | Length 90 mm | In distribution |
| 0110-75060 | Length 60 mm | In distribution |
| 0102-75080 | Outer Diameter 7.5 mm | In distribution |
| 0110-85070 | Length 70 mm | In distribution |
| 0117-70060 | Length 60 mm | In distribution |
| 0102-65035 | Outer Diameter 6.5 mm | In distribution |
| 0117-90030 | Outer Diameter 9 mm | In distribution |
| 0102-10060 | Length 60 mm | In distribution |
| 0104-55100 | Length 100 mm | In distribution |
| 0117-55030 | Outer Diameter 5.5 mm | In distribution |
| 0107-55085 | Outer Diameter 5.5 mm | In distribution |
| 0122-55045 | Length 45 mm | In distribution |
| 0110-10085 | Length 85 mm | In distribution |
| 0114-60050 | Length 50 mm | In distribution |
| 0102-85060 | Outer Diameter 8.5 mm | In distribution |
| 0102-85055 | Length 55 mm | In distribution |
| 0102-60035 | Length 35 mm | In distribution |
| 0110-75030 | Outer Diameter 7.5 mm | In distribution |
| 0114-95060 | Length 60 mm | In distribution |
| 0110-65080 | Length 80 mm | In distribution |
| 0114-90040 | Outer Diameter 9 mm | In distribution |
| 0102-50060 | Outer Diameter 5 mm | In distribution |
| 0106-55055 | Length 55 mm | In distribution |
| 0117-75060 | Length 60 mm | In distribution |
| 0117-70095 | Outer Diameter 7 mm | In distribution |
| 0110-55030 | Outer Diameter 5.5 mm | In distribution |
| 0121-55060 | Length 60 mm | In distribution |
| 0117-95060 | Length 60 mm | In distribution |
| 0117-65045 | Length 45 mm | In distribution |
| 0107-55075 | Length 75 mm | In distribution |
| 0117-70045 | Length 45 mm | In distribution |
| 0117-70085 | Outer Diameter 7 mm | In distribution |
| 0115-50035 | Length 35 mm | In distribution |
| 0102-95065 | Length 65 mm | In distribution |
| 0102-75050 | Outer Diameter 7.5 mm | In distribution |
| 0110-85050 | Outer Diameter 8.5 mm | In distribution |
| 0102-70040 | Outer Diameter 7 mm | In distribution |
| 0106-55300 | Length 300 mm | In distribution |
| 0110-10090 | Outer Diameter 10 mm | In distribution |
| 0110-10035 | Length 35 mm | In distribution |
| 0110-65095 | Length 95 mm | In distribution |
| 0117-70035 | Length 35 mm | In distribution |
| 0116-55100 | Outer Diameter 5.5 mm | In distribution |
| 0110-95040 | Outer Diameter 9.5 mm | In distribution |
| 0104-55110 | Length 110 mm | In distribution |
| 0105-55070 | Outer Diameter 5.5 mm | In distribution |
| 0102-55045 | Outer Diameter 5.5 mm | In distribution |
| 0114-95055 | Outer Diameter 9.5 mm | In distribution |
| 0114-65050 | Length 50 mm | In distribution |
| 0102-50055 | Outer Diameter 5 mm | In distribution |
| 0110-90065 | Outer Diameter 9 mm | In distribution |
| 0114-80040 | Outer Diameter 8 mm | In distribution |
| 0114-75055 | Outer Diameter 7.5 mm | In distribution |
| 0122-55075 | Length 75 mm | In distribution |
| 0114-95065 | Length 65 mm | In distribution |
| 0106-55100 | Outer Diameter 5.5 mm | In distribution |
| 0110-90035 | Outer Diameter 9 mm | In distribution |
| 0114-70065 | Length 65 mm | In distribution |
| 0121-55080 | Outer Diameter 5.5 mm | In distribution |
| 0114-70080 | Outer Diameter 7 mm | In distribution |
| 0117-75085 | Length 85 mm | In distribution |
| 0110-65060 | Length 60 mm | In distribution |
| 0106-55130 | Length 130 mm | In distribution |
| 0122-55400 | Outer Diameter 5.5 mm | In distribution |
| 0117-55055 | Length 55 mm | In distribution |
| 0117-70040 | Length 40 mm | In distribution |
| 0114-90065 | Length 65 mm | In distribution |
| 0116-50050 | Outer Diameter 5.5 mm | In distribution |
| 0116-50045 | Outer Diameter 5.5 mm | In distribution |
| 0102-65045 | Outer Diameter 6.5 mm | In distribution |
| 0102-95070 | Outer Diameter 9.5 mm | In distribution |
| 0102-65040 | Length 40 mm | In distribution |
| 0110-95030 | Length 30 mm | In distribution |
| 0114-65055 | Outer Diameter 6.5 mm | In distribution |
| 0106-55200 | Length 200 mm | In distribution |
| 0121-55045 | Length 45 mm | In distribution |
| 0102-95095 | Outer Diameter 9.5 mm | In distribution |
| 0110-50040 | Outer Diameter 5 mm | In distribution |
| 0114-85075 | Outer Diameter 8.5 mm | In distribution |
| 0117-70065 | Length 65 mm | In distribution |
| 0110-85080 | Length 80 mm | In distribution |
| 0105-55035 | Length 35 mm | In distribution |
| 0104-55030 | Outer Diameter 5.5 mm | In distribution |
| 0102-65030 | Length 30 mm | In distribution |
| 0117-95080 | Length 80 mm | In distribution |
| 0114-70090 | Outer Diameter 7 mm | In distribution |
| 0117-50040 | Outer Diameter 5 mm | In distribution |
| 0115-55065 | Outer Diameter 5.5 mm | In distribution |
| 0102-50050 | Length 50 mm | In distribution |
| 0117-10060 | Length 60 mm | In distribution |
| 0122-55085 | Length 85 mm | In distribution |
| 0102-50035 | Length 35 mm | In distribution |
| 0114-70030 | Length 30 mm | In distribution |
| 0117-90060 | Outer Diameter 9 mm | In distribution |
| 0106-55050 | Outer Diameter 5.5 mm | In distribution |
| 0117-80085 | Outer Diameter 8 mm | In distribution |
| 0114-70095 | Length 95 mm | In distribution |
| 0117-60050 | Outer Diameter 6 mm | In distribution |
| 0117-75095 | Length 95 mm | In distribution |
| 0110-75075 | Outer Diameter 7.5 mm | In distribution |
| 0114-10045 | Outer Diameter 10 mm | In distribution |
| 0122-55480 | Length 480 mm | In distribution |
| 0102-85050 | Length 50 mm | In distribution |
| 0110-95095 | Outer Diameter 9.5 mm | In distribution |
| 0106-55045 | Length 45 mm | In distribution |
| 0105-55040 | Outer Diameter 5.5 mm | In distribution |
| 0116-55085 | Outer Diameter 5.5 mm | In distribution |
| 0104-55400 | Outer Diameter 5.5 mm | In distribution |
| 0116-55300 | Length 300 mm | In distribution |
| 0117-95070 | Outer Diameter 9.5 mm | In distribution |
| 0117-95065 | Outer Diameter 9.5 mm | In distribution |
| 0121-55030 | Length 30 mm | In distribution |
| 0110-80070 | Length 70 mm | In distribution |
| 0114-90060 | Outer Diameter 9 mm | In distribution |
| 0122-55095 | Outer Diameter 5.5 mm | In distribution |
| 0117-10070 | Outer Diameter 10 mm | In distribution |
| 0110-10065 | Outer Diameter 10 mm | In distribution |
| 0110-75055 | Outer Diameter 7.5 mm | In distribution |
| 0114-70045 | Outer Diameter 7 mm | In distribution |
| 0117-90095 | Length 95 mm | In distribution |
| 0121-55070 | Outer Diameter 5.5 mm | In distribution |
| 0117-70075 | Length 75 mm | In distribution |
| 0102-95075 | Outer Diameter 9.5 mm | In distribution |
| 0117-85050 | Outer Diameter 8.5 mm | In distribution |
| 0117-85030 | Outer Diameter 8.5 mm | In distribution |
| 0121-55100 | Outer Diameter 5.5 mm | In distribution |
| 0114-65070 | Outer Diameter 6.5 mm | In distribution |
| 0110-50045 | Length 45 mm | In distribution |
| 0102-80080 | Outer Diameter 8 mm | In distribution |
| 0117-55040 | Length 40 mm | In distribution |
| 0110-85055 | Outer Diameter 8.5 mm | In distribution |
| 0110-80065 | Outer Diameter 8 mm | In distribution |
| 0110-10050 | Length 50 mm | In distribution |
| 0110-70095 | Length 95 mm | In distribution |
| 0102-10065 | Length 65 mm | In distribution |
| 0107-55120 | Outer Diameter 5.5 mm | In distribution |
| 0122-55120 | Length 120 mm | In distribution |
| 0110-70075 | Outer Diameter 7 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Creo | Globus Medical, Inc. | 1,821 |
| ReLine | Nuvasive, Inc. | 1,093 |
| Olympic | Astura Medical | 951 |
| Nex-D2 | Next Orthosurgical | 887 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 876 |
| Arsenal | Alphatec Spine, Inc. | 820 |
| Apex-DL Spine System | Spinecraft LLC | 691 |
| Polaris™ 4.75 Spinal System | Biomet Spine | 413 |
| Expedium | Medos International Sàrl | 400 |
| Implanet Spine System | Implanet | 386 |
| Everest® Spinal System | VB Spine LLC | 299 |
| Arsenal Deformity Spinal Fixation System | Alphatec Spine, Inc. | 258 |
Showing 12 of 73. All products under Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
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.