PedFuse®
Pedicle Screw Assembly, REturn, Solid Screw Ø5.0mm x 40mm
13manufacturers in China registered for this device type
561catalogue numbers in this listing
1510(k) clearance
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 | Spinefrontier, Inc., United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K092420 |
| Record published | 2016-04-15 |
| 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 20 to 500 mm; outer diameter 5 to 11.9 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-80045-50 | Length 50 mm | In distribution |
| 01-80143-70 | Outer Diameter 7 mm | In distribution |
| 01-80139-30R | Outer Diameter 5 mm | In distribution |
| 01-80144-40R | Length 40 mm | In distribution |
| IM80102-07 | Length 60 mm | In distribution |
| 01-80145-35R | Length 35 mm | In distribution |
| 01-80120-5555 | Outer Diameter 5.5 mm | In distribution |
| 01-80047-40 | Outer Diameter 5 mm | In distribution |
| 01-80050-45 | Length 45 mm | In distribution |
| 01-80025-80 | Length 80 mm | In distribution |
| 01-80017-40 | Outer Diameter 9 mm | In distribution |
| 01-80068-60 | Length 60 mm | In distribution |
| 01-80142-50R | Outer Diameter 6 mm | In distribution |
| 01-80111-5575 | Outer Diameter 5.5 mm | In distribution |
| 01-80189-80 | Outer Diameter 7 mm | In distribution |
| IM80189-01 | Outer Diameter 6 mm | In distribution |
| 01-80141-40 | Length 40 mm | In distribution |
| 01-80145-55R | Outer Diameter 5.5 mm | In distribution |
| 01-80186-35 | Length 35 mm | In distribution |
| 01-80134-60R | Outer Diameter 7 mm | In distribution |
| 01-80108-40 | Outer Diameter 5 mm | In distribution |
| 01-80122-35 | Length 35 mm | In distribution |
| 01-80051-35 | Length 35 mm | In distribution |
| 01-80028-70 | Length 70 mm | In distribution |
| 01-80025-50 | Length 50 mm | In distribution |
| 01-80180-60 | Outer Diameter 7 mm | In distribution |
| 01-80135-35R | Outer Diameter 5 mm | In distribution |
| 01-80136-55R | Outer Diameter 5.5 mm | In distribution |
| 01-80136-55 | Length 55 mm | In distribution |
| 01-80143-80 | Length 80 mm | In distribution |
| 01-80110-35 | Outer Diameter 7 mm | In distribution |
| 01-80046-60 | Length 60 mm | In distribution |
| IM80020-04 | Length 45 mm | In distribution |
| 01-80165-5535 | Outer Diameter 5.5 mm | In distribution |
| 01-80188-45 | Outer Diameter 7 mm | In distribution |
| 01-80051-55 | Outer Diameter 9 mm | In distribution |
| 01-80123-30 | Length 30 mm | In distribution |
| 01-80169-40R | Length 40 mm | In distribution |
| 01-80119-75 | Outer Diameter 7 mm | In distribution |
| 01-80188-70 | Length 70 mm | In distribution |
| 01-80146-35R | Outer Diameter 6 mm | In distribution |
| 01-80145-30R | Outer Diameter 5.5 mm | In distribution |
| 01-80188-20 | Length 20 mm | In distribution |
| 01-80144-35R | Outer Diameter 5 mm | In distribution |
| 01-80005-20 | Length 20 mm | In distribution |
| 01-80076-80 | Outer Diameter 7 mm | In distribution |
| 01-80143-45R | Length 45 mm | In distribution |
| 01-80134-70 | Outer Diameter 7 mm | In distribution |
| 01-80022-80 | Length 80 mm | In distribution |
| IM80023-03 | Length 40 mm | In distribution |
| 01-80120-5545 | Outer Diameter 5.5 mm | In distribution |
| 01-80130-60 | Outer Diameter 9 mm | In distribution |
| 01-80016-50 | Length 50 mm | In distribution |
| 01-80146-45R | Outer Diameter 6 mm | In distribution |
| 01-80141-55 | Outer Diameter 5.5 mm | In distribution |
| 01-80115-80 | Length 80 mm | In distribution |
| 01-80186-45 | Length 45 mm | In distribution |
| 01-80047-35 | Outer Diameter 5 mm | In distribution |
| 01-80182-55 | Outer Diameter 6 mm | In distribution |
| IM80100-05 | Outer Diameter 5.5 mm | In distribution |
| IM80102-04 | Length 45 mm | In distribution |
| 01-80080-55 | Outer Diameter 6 mm | In distribution |
| 01-80076-75 | Outer Diameter 7 mm | In distribution |
| 01-80169-55R | Outer Diameter 6.5 mm | In distribution |
| 01-80134-50 | Length 50 mm | In distribution |
| 01-80076-35 | Length 35 mm | In distribution |
| 01-80050-80 | Length 80 mm | In distribution |
| 01-80025-200 | Length 200 mm | In distribution |
| 01-80128-50 | Length 50 mm | In distribution |
| 01-80005-25 | Length 25 mm | In distribution |
| 01-80080-50 | Length 50 mm | In distribution |
| 01-80025-85 | Outer Diameter 5.5 mm | In distribution |
| IM80188-02 | Length 35 mm | In distribution |
| 01-80164-55150 | Outer Diameter 5.5 mm | In distribution |
| 01-80165-55170 | Outer Diameter 5.5 mm | In distribution |
| 01-80139-20R | Length 20 mm | In distribution |
| 01-80180-65 | Length 65 mm | In distribution |
| 01-80183-65 | Length 65 mm | In distribution |
| 01-80120-55170 | Outer Diameter 5.5 mm | In distribution |
| 01-80024-30 | Length 30 mm | In distribution |
| 01-80170-35R | Outer Diameter 6.5 mm | In distribution |
| 01-80124-55 | Length 55 mm | In distribution |
| 01-80137-50 | Length 50 mm | In distribution |
| 01-85010-40R | Length 40 mm | In distribution |
| 01-80170-55R | Outer Diameter 6.5 mm | In distribution |
| 01-80170-35 | Length 35 mm | In distribution |
| 01-80136-40R | Outer Diameter 5.5 mm | In distribution |
| IM80024-04 | Length 45 mm | In distribution |
| 01-80121-50 | Outer Diameter 5 mm | In distribution |
| 01-80165-55100 | Outer Diameter 5.5 mm | In distribution |
| IM80021-04 | Outer Diameter 6 mm | In distribution |
| 01-80020-55 | Outer Diameter 6 mm | In distribution |
| 01-80133-45 | Length 45 mm | In distribution |
| 01-80025-150 | Outer Diameter 5.5 mm | In distribution |
| 01-80024-65 | Outer Diameter 8 mm | In distribution |
| 01-80147-30 | Outer Diameter 7 mm | In distribution |
| 01-80117-50 | Length 50 mm | In distribution |
| 01-80014-45 | Outer Diameter 7 mm | In distribution |
| 01-80177-45 | Length 45 mm | In distribution |
| 01-80109-45 | Length 45 mm | In distribution |
| 01-80025-170 | Outer Diameter 5.5 mm | In distribution |
| 01-80134-80R | Outer Diameter 7 mm | In distribution |
| IM80103-02 | Length 45 mm | In distribution |
| 01-80051-50 | Length 50 mm | In distribution |
| 01-80170-45 | Length 45 mm | In distribution |
| 01-80139-40 | Length 40 mm | In distribution |
| 01-80130-70 | Outer Diameter 9 mm | In distribution |
| 01-80068-110 | Outer Diameter 5.5 mm | In distribution |
| 01-80189-50 | Outer Diameter 7 mm | In distribution |
| 01-80012-50 | Length 50 mm | In distribution |
| 01-80141-20 | Outer Diameter 5.5 mm | In distribution |
| 01-80125-75 | Length 75 mm | In distribution |
| 01-80117-45 | Outer Diameter 5 mm | In distribution |
| IM80024-11 | Length 80 mm | In distribution |
| 01-80119-40 | Length 40 mm | In distribution |
| 01-80009-50 | Length 50 mm | In distribution |
| 01-80008-70 | Length 70 mm | In distribution |
| 01-80184-25 | Outer Diameter 5 mm | In distribution |
| IM80190-08 | Outer Diameter 7 mm | In distribution |
| 01-80008-50 | Length 50 mm | In distribution |
| IM80023-05 | Outer Diameter 8 mm | In distribution |
| 01-80046-30 | Length 30 mm | In distribution |
| 01-80123-40 | Length 40 mm | In distribution |
| 01-80024-75 | Length 75 mm | In distribution |
| IM80100-02 | Length 35 mm | In distribution |
| 01-80147-80R | Length 80 mm | In distribution |
| 01-80138-30 | Outer Diameter 7 mm | In distribution |
| IM80100-13 | Outer Diameter 5.5 mm | In distribution |
| IM80100-17 | Length 150 mm | In distribution |
| IM80102-05 | Outer Diameter 5.5 mm | In distribution |
| 01-80125-60 | Length 60 mm | In distribution |
| 01-80017-35 | Outer Diameter 9 mm | In distribution |
| 01-80170-30 | Length 30 mm | In distribution |
| 01-80017-75 | Length 75 mm | In distribution |
| 01-80145-35 | Outer Diameter 5.5 mm | In distribution |
| IM80022-08 | Outer Diameter 7 mm | In distribution |
| 01-80077-50 | Length 50 mm | In distribution |
| 01-80124-80 | Outer Diameter 8 mm | In distribution |
| 01-80143-55R | Outer Diameter 7 mm | In distribution |
| IM80024-09 | Outer Diameter 9 mm | In distribution |
| 01-80068-40 | Length 40 mm | In distribution |
| IM80100-20 | Length 500 mm | In distribution |
| 01-80146-50 | Length 50 mm | In distribution |
| 01-80189-60 | Outer Diameter 7 mm | In distribution |
| 01-80138-35R | Length 35 mm | In distribution |
| 01-80077-45 | Outer Diameter 8 mm | In distribution |
| 01-80119-70 | Length 70 mm | In distribution |
| IM80023-07 | Length 60 mm | In distribution |
| IM80020-03 | Outer Diameter 5 mm | In distribution |
| 01-80165-5570 | Outer Diameter 5.5 mm | In distribution |
| 01-80138-50 | Length 50 mm | In distribution |
| 01-80078-55 | Outer Diameter 9 mm | In distribution |
| 01-80005-50 | Outer Diameter 5 mm | In distribution |
| 01-80022-20 | Outer Diameter 7 mm | In distribution |
| 01-80028-30 | Outer Diameter 9 mm | In distribution |
| 01-80143-40 | Length 40 mm | In distribution |
| 01-80132-25R | Outer Diameter 5.5 mm | In distribution |
| 01-80009-75 | Length 75 mm | In distribution |
| 01-80010-45 | Length 45 mm | In distribution |
| 01-80080-45 | Outer Diameter 6 mm | In distribution |
| 01-80027-30 | Length 30 mm | In distribution |
| 01-80186-40 | Length 40 mm | In distribution |
| 01-80170-40R | Length 40 mm | In distribution |
| 01-80147-65R | Outer Diameter 7 mm | In distribution |
| 01-80189-35 | Outer Diameter 7 mm | In distribution |
| IM80023-08 | Length 65 mm | In distribution |
| 01-80147-65 | Outer Diameter 7 mm | In distribution |
| 01-85010-65R | Length 65 mm | In distribution |
| 01-80025-45 | Outer Diameter 5.5 mm | In distribution |
| 01-80051-70 | Length 70 mm | In distribution |
| 01-80051-65 | Length 65 mm | In distribution |
| 01-80138-80R | Outer Diameter 7 mm | In distribution |
| 01-80025-120 | Outer Diameter 5.5 mm | In distribution |
| IM80190-01 | Outer Diameter 7 mm | In distribution |
| IM80190-04 | Outer Diameter 7 mm | In distribution |
| 01-80185-50 | Length 50 mm | In distribution |
| 01-80132-55 | Length 55 mm | In distribution |
| 01-80046-70 | Outer Diameter 7 mm | In distribution |
| 01-80111-5550 | Outer Diameter 5.5 mm | In distribution |
| 01-80132-40 | Outer Diameter 5.5 mm | In distribution |
| IM80190-05 | Length 50 mm | In distribution |
| 01-80117-25 | Outer Diameter 5 mm | In distribution |
| 01-80165-55150 | Length 150 mm | In distribution |
| IM80100-14 | Length 110 mm | In distribution |
| 01-80180-55 | Length 55 mm | In distribution |
| 01-80110-30 | Outer Diameter 7 mm | In distribution |
| 01-80130-40 | Length 40 mm | In distribution |
| 01-80181-35 | Outer Diameter 5 mm | In distribution |
| 01-80068-90 | Length 90 mm | In distribution |
| 01-80118-55 | Length 55 mm | In distribution |
| 01-80022-45 | Length 45 mm | In distribution |
| 01-80117-40 | Length 40 mm | In distribution |
| 01-80078-80 | Length 80 mm | In distribution |
| 01-80143-35R | Length 35 mm | In distribution |
| 01-80164-5565 | Outer Diameter 5.5 mm | In distribution |
| 01-85008-35 | Outer Diameter 5 mm | In distribution |
| 01-85010-70 | Length 70 mm | In distribution |
| 01-80118-40 | Length 40 mm | In distribution |
| 01-80143-55 | Length 55 mm | In distribution |
| 01-80111-5555 | Outer Diameter 5.5 mm | In distribution |
| IM80024-10 | Length 75 mm | In distribution |
| 01-80139-50R | Outer Diameter 5 mm | In distribution |
| 01-80007-65 | Length 65 mm | In distribution |
| 01-80012-35 | Length 35 mm | In distribution |
| 01-80146-55R | Length 55 mm | In distribution |
| 01-80184-35 | Outer Diameter 5 mm | In distribution |
| 01-80022-60 | Outer Diameter 7 mm | In distribution |
| 01-80008-60 | Length 60 mm | In distribution |
| 01-80024-45 | Length 45 mm | In distribution |
| 01-80142-40R | Outer Diameter 6 mm | In distribution |
| 01-80147-30R | Length 30 mm | In distribution |
| 01-80164-5570 | Outer Diameter 5.5 mm | In distribution |
| 01-80147-50R | Outer Diameter 7 mm | In distribution |
| 01-80140-40 | Length 40 mm | In distribution |
| 01-80124-65 | Outer Diameter 8 mm | In distribution |
| 01-80027-35 | Length 35 mm | In distribution |
| 01-80117-20 | Length 20 mm | In distribution |
| 01-80147-60R | Outer Diameter 7 mm | In distribution |
| 01-80138-60 | Length 60 mm | In distribution |
| 01-80025-65 | Length 65 mm | In distribution |
| 01-80049-55 | Outer Diameter 7 mm | In distribution |
| 01-80177-65 | Length 65 mm | In distribution |
| 01-80125-80 | Length 80 mm | In distribution |
| 01-80137-35 | Length 35 mm | In distribution |
| 01-80007-30 | Length 30 mm | In distribution |
| 01-80164-5535 | Outer Diameter 5.5 mm | In distribution |
| 01-80111-55150 | Length 150 mm | In distribution |
| 01-80189-70 | Length 70 mm | In distribution |
| IM80100-06 | Length 55 mm | In distribution |
| 01-80164-55110 | Length 110 mm | In distribution |
| 01-80045-40 | Length 40 mm | In distribution |
| 01-80108-35 | Outer Diameter 5 mm | In distribution |
| 01-80141-30 | Outer Diameter 5.5 mm | In distribution |
| 01-80187-20 | Outer Diameter 6 mm | In distribution |
| 01-80143-75R | Length 75 mm | In distribution |
| 01-80076-55 | Length 55 mm | In distribution |
| 01-80170-30R | Length 30 mm | In distribution |
| 01-80139-35 | Length 35 mm | In distribution |
| 01-80132-45 | Length 45 mm | In distribution |
| 01-80187-35 | Outer Diameter 6 mm | In distribution |
| 01-80118-35 | Outer Diameter 6 mm | In distribution |
| 01-80138-50R | Outer Diameter 7 mm | In distribution |
| 01-80025-130 | Length 130 mm | In distribution |
| 01-80165-5560 | Length 60 mm | In distribution |
| 01-80123-75 | Outer Diameter 7 mm | In distribution |
| 01-80147-75 | Outer Diameter 7 mm | In distribution |
| 01-80187-50 | Length 50 mm | In distribution |
| 01-80115-60 | Outer Diameter 8 mm | In distribution |
| 01-80117-35 | Outer Diameter 5 mm | In distribution |
| 01-80076-30 | Outer Diameter 7 mm | In distribution |
Showing 250 of 300 catalogue numbers.
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K092420 | 2009-11-19 |
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Spinefrontier, Inc. DBA LESspine Innovations | 510(k) number | 2013-11-20 | Class II | Device Design | Screw inserters may not mate properly with hex interface of the screws. | 4 | 2018-06-26 |
| Spinefrontier, Inc. DBA LESspine Innovations | 510(k) number | 2013-11-20 | Class II | Device Design | Screw inserters may not mate properly with hex interface of the screws. | 25 | 2018-06-26 |
| Spinefrontier, Inc. DBA LESspine Innovations | 510(k) number | 2013-11-20 | Class II | Device Design | Screw inserters may not mate properly with hex interface of the screws. | 13 | 2018-06-26 |
| Spinefrontier, Inc. DBA LESspine Innovations | 510(k) number | 2013-10-18 | Class II | Software design (manufacturing process) | During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have consisted of an 8mm tulip head and an 8mm screw. A recall was initiated to remove all re | 35 Devices | 2016-08-22 |
| Spinefrontier, Inc. DBA LESspine Innovations | 510(k) number | 2011-12-30 | Class II | Vendor change control | One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 dynamic compression testing 5 million cycles. | 2 rods | 2014-01-08 |
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.