PedFuse®
Pedicle Screw Assembly, REturn, Solid Screw Ø5.0mm x 30mm
13manufacturers in China registered for this device type
488catalogue numbers in this listing
3510(k) clearances naming this product code
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, Spondylolisthesis Spinal Fixation
Record
| Listed by | Spinefrontier, Inc., United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal 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 9 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-80078-70 | Outer Diameter 9 mm | In distribution |
| 01-80076-70 | Outer Diameter 7 mm | In distribution |
| 01-80136-35 | Length 35 mm | In distribution |
| 01-80009-35 | Length 35 mm | In distribution |
| IM80102-14 | Outer Diameter 5.5 mm | In distribution |
| 01-80125-50 | Length 50 mm | In distribution |
| 01-80047-30 | Outer Diameter 5 mm | In distribution |
| 01-80115-35 | Outer Diameter 8 mm | In distribution |
| 01-80120-5590 | Outer Diameter 5.5 mm | In distribution |
| IM80190-09 | Outer Diameter 7 mm | In distribution |
| 01-80111-5540 | Outer Diameter 5.5 mm | In distribution |
| IM80022-09 | Length 70 mm | In distribution |
| 01-80134-35 | Length 35 mm | In distribution |
| 01-80022-70 | Length 70 mm | In distribution |
| IM80022-02 | Length 35 mm | In distribution |
| 01-80122-50 | Length 50 mm | In distribution |
| 01-80133-40R | Outer Diameter 6 mm | In distribution |
| 01-80127-35 | Outer Diameter 6 mm | In distribution |
| IM80022-07 | Outer Diameter 7 mm | In distribution |
| 01-80068-50 | Length 50 mm | In distribution |
| IM80103-12 | Length 35 mm | In distribution |
| 01-80048-50 | Length 50 mm | In distribution |
| 01-80128-60 | Length 60 mm | In distribution |
| 01-80141-30R | Length 30 mm | In distribution |
| 01-85009-50 | Length 50 mm | In distribution |
| 01-85010-45 | Outer Diameter 7 mm | In distribution |
| 01-80133-50 | Outer Diameter 6 mm | In distribution |
| 01-80133-45R | Outer Diameter 6 mm | In distribution |
| 01-80169-45R | Length 45 mm | In distribution |
| 01-80109-35 | Outer Diameter 6 mm | In distribution |
| 01-80068-85 | Outer Diameter 5.5 mm | In distribution |
| 01-80111-5585 | Outer Diameter 5.5 mm | In distribution |
| 01-80016-70 | Outer Diameter 8 mm | In distribution |
| 01-80007-60 | Outer Diameter 7 mm | In distribution |
| IM80102-13 | Outer Diameter 5.5 mm | In distribution |
| 01-80077-40 | Length 40 mm | In distribution |
| IM80023-06 | Length 55 mm | In distribution |
| 01-85008-45R | Length 45 mm | In distribution |
| 01-80108-30 | Length 30 mm | In distribution |
| IM80100-12 | Length 90 mm | In distribution |
| 01-80111-55100 | Length 100 mm | In distribution |
| 01-80051-45 | Length 45 mm | In distribution |
| 01-80006-50 | Outer Diameter 6 mm | In distribution |
| IM80020-02 | Length 35 mm | In distribution |
| 01-80120-55110 | Length 110 mm | In distribution |
| 01-80100 | In distribution | |
| 01-80124-40 | Outer Diameter 8 mm | In distribution |
| 01-80068-120 | Length 120 mm | In distribution |
| 01-80005-35 | Length 35 mm | In distribution |
| 01-80117-30 | Length 30 mm | In distribution |
| 01-80183-45 | Length 45 mm | In distribution |
| 01-80049-80 | Outer Diameter 7 mm | In distribution |
| 01-80143-40R | Length 40 mm | In distribution |
| 01-80187-25 | Length 25 mm | In distribution |
| 01-80135-45R | Length 45 mm | In distribution |
| 01-80147-75R | Outer Diameter 7 mm | In distribution |
| 01-80115-65 | Length 65 mm | In distribution |
| 01-80189-75 | Length 75 mm | In distribution |
| 01-80179-50 | Outer Diameter 6 mm | In distribution |
| IM80189-06 | Length 55 mm | In distribution |
| 01-80144-30R | Outer Diameter 5 mm | In distribution |
| 01-80014-60 | Length 60 mm | In distribution |
| 01-80169-35 | Outer Diameter 6.5 mm | In distribution |
| 01-80145-50 | Outer Diameter 5.5 mm | In distribution |
| 01-80142-45R | Length 45 mm | In distribution |
| 01-85010-60R | Outer Diameter 7 mm | In distribution |
| 01-80120-5585 | Length 85 mm | In distribution |
| 01-80178-50 | Length 50 mm | In distribution |
| 01-80138-55R | Length 55 mm | In distribution |
| 01-85009-55 | Length 55 mm | In distribution |
| 01-80077-75 | Outer Diameter 8 mm | In distribution |
| 01-80137-40R | Outer Diameter 6 mm | In distribution |
| IM80190-03 | Outer Diameter 7 mm | In distribution |
| 01-80137-50R | Length 50 mm | In distribution |
| IM80192 | In distribution | |
| 01-80012-45 | Length 45 mm | In distribution |
| 01-80080-35 | Length 35 mm | In distribution |
| 01-80007-70 | Outer Diameter 7 mm | In distribution |
| 01-80179-40 | Length 40 mm | In distribution |
| 01-85010-50R | Length 50 mm | In distribution |
| 01-80111-55110 | Length 110 mm | In distribution |
| 01-80183-55 | Outer Diameter 7 mm | In distribution |
| 01-80009-80 | Length 80 mm | In distribution |
| 01-80165-5545 | Length 45 mm | In distribution |
| 01-80130-50 | Outer Diameter 9 mm | In distribution |
| 01-80182-30 | Length 30 mm | In distribution |
| 01-80074-45 | Length 45 mm | In distribution |
| 01-80051-40 | Outer Diameter 9 mm | In distribution |
| 01-80146-40 | Length 40 mm | In distribution |
| 01-80133-35 | Outer Diameter 6 mm | In distribution |
| IM80100-01 | Outer Diameter 5.5 mm | In distribution |
| 01-80020-50 | Length 50 mm | In distribution |
| 01-80048-30 | Outer Diameter 6 mm | In distribution |
| 01-80016-75 | Length 75 mm | In distribution |
| 01-80045-30 | Length 30 mm | In distribution |
| 01-80164-5550 | Outer Diameter 5.5 mm | In distribution |
| 01-80143-65R | Length 65 mm | In distribution |
| 01-80165-55130 | Length 130 mm | In distribution |
| 01-80128-65 | Length 65 mm | In distribution |
| 01-80025-90 | Outer Diameter 5.5 mm | In distribution |
| 01-80140-25R | Length 25 mm | In distribution |
| 01-80078-40 | Length 40 mm | In distribution |
| IM80103-09 | Length 93 mm | In distribution |
| 01-80143-70R | Length 70 mm | In distribution |
| 01-80119-50 | Length 50 mm | In distribution |
| 01-80132-55R | Length 55 mm | In distribution |
| 01-80024-35 | Length 35 mm | In distribution |
| 01-80132-30R | Length 30 mm | In distribution |
| 01-80141-35R | Outer Diameter 5.5 mm | In distribution |
| 01-80137-40 | Outer Diameter 6 mm | In distribution |
| 01-80144-45 | Length 45 mm | In distribution |
| 01-80143-60 | Outer Diameter 7 mm | In distribution |
| 01-80123-80 | Length 80 mm | In distribution |
| 01-80146-30R | Length 30 mm | In distribution |
| 01-80121-30 | Outer Diameter 5 mm | In distribution |
| IM80188-04 | Length 45 mm | In distribution |
| 01-80134-40R | Length 40 mm | In distribution |
| 01-80170-55 | Length 55 mm | In distribution |
| 01-80068-70 | Outer Diameter 5.5 mm | In distribution |
| 01-80145-50R | Length 50 mm | In distribution |
| IM80024-07 | Length 60 mm | In distribution |
| 01-80183-75 | Length 75 mm | In distribution |
| 01-80142-30R | Length 30 mm | In distribution |
| 01-80120-5560 | Outer Diameter 5.5 mm | In distribution |
| 01-80018-25 | Length 25 mm | In distribution |
| 01-80142-45 | Outer Diameter 6 mm | In distribution |
| 01-80130-65 | Length 65 mm | In distribution |
| 01-80138-30R | Length 30 mm | In distribution |
| 01-80179-30 | Length 30 mm | In distribution |
| 01-80132-25 | Length 25 mm | In distribution |
| 01-80027-55 | Length 55 mm | In distribution |
| 01-80047-50 | Outer Diameter 5 mm | In distribution |
| 01-80111-5580 | Length 80 mm | In distribution |
| 01-80144-50R | Length 50 mm | In distribution |
| 01-80139-30 | Outer Diameter 5 mm | In distribution |
| 01-80128-55 | Length 55 mm | In distribution |
| 01-80143-50R | Outer Diameter 7 mm | In distribution |
| 01-80180-70 | Length 70 mm | In distribution |
| IM80100-08 | Outer Diameter 5.5 mm | In distribution |
| 01-80076-65 | Length 65 mm | In distribution |
| 01-80132-30 | Outer Diameter 5.5 mm | In distribution |
| 01-80077-60 | Outer Diameter 8 mm | In distribution |
| 01-80020-20 | Outer Diameter 6 mm | In distribution |
| 01-80115-30 | Length 30 mm | In distribution |
| 01-80024-40 | Length 40 mm | In distribution |
| 01-80146-35 | Length 35 mm | In distribution |
| 01-80206 | In distribution | |
| IM80022-05 | Outer Diameter 7 mm | In distribution |
| 01-80077-35 | Length 35 mm | In distribution |
| 01-80115-50 | Outer Diameter 8 mm | In distribution |
| 01-80147-80 | Outer Diameter 7 mm | In distribution |
| 01-80050-65 | Length 65 mm | In distribution |
| 01-80024-60 | Length 60 mm | In distribution |
| 01-80184-50 | Length 50 mm | In distribution |
| 01-80007-40 | Length 40 mm | In distribution |
| 01-80110-75 | Length 75 mm | In distribution |
| 01-80134-55 | Length 55 mm | In distribution |
| 01-80022-65 | Length 65 mm | In distribution |
| 01-80009-65 | Length 65 mm | In distribution |
| 01-80024-70 | Length 70 mm | In distribution |
| IM80022-10 | Length 75 mm | In distribution |
| 01-80147-40R | Outer Diameter 7 mm | In distribution |
| 01-80180-40 | Outer Diameter 7 mm | In distribution |
| 01-80137-55 | Outer Diameter 6 mm | In distribution |
| 01-80165-5555 | Outer Diameter 5.5 mm | In distribution |
| 01-80133-55 | Length 55 mm | In distribution |
| 01-80046-80 | Outer Diameter 7 mm | In distribution |
| 01-80184-45 | Length 45 mm | In distribution |
| 01-80110-70 | Length 70 mm | In distribution |
| 01-80121-35 | Length 35 mm | In distribution |
| 01-80128-45 | Length 45 mm | In distribution |
| 01-85010-75R | Length 75 mm | In distribution |
| 01-80164-55130 | Length 130 mm | In distribution |
| 01-80138-65 | Length 65 mm | In distribution |
| 01-80145-30 | Length 30 mm | In distribution |
| 01-80110-65 | Length 65 mm | In distribution |
| 01-80078-60 | Outer Diameter 9 mm | In distribution |
| 01-80120-5580 | Length 80 mm | In distribution |
| 01-80133-40 | Length 40 mm | In distribution |
| 01-80115-75 | Outer Diameter 8 mm | In distribution |
| IM80023-04 | Outer Diameter 8 mm | In distribution |
| 01-80028-35 | Length 35 mm | In distribution |
| 01-80144-40 | Length 40 mm | In distribution |
| 01-80135-35 | Length 35 mm | In distribution |
| 01-80077-80 | Length 80 mm | In distribution |
| IM80190-07 | Length 60 mm | In distribution |
| 01-80143-30 | Length 30 mm | In distribution |
| 01-80005-30 | Outer Diameter 5 mm | In distribution |
| 01-80134-60 | Outer Diameter 7 mm | In distribution |
| 01-80164-5585 | Length 85 mm | In distribution |
| 01-80136-40 | Outer Diameter 5.5 mm | In distribution |
| 01-80025-30 | Outer Diameter 5.5 mm | In distribution |
| 01-85010-40 | Length 40 mm | In distribution |
| 01-80129-35 | Outer Diameter 8 mm | In distribution |
| 01-80129-60 | Length 60 mm | In distribution |
| 01-80012-55 | Length 55 mm | In distribution |
| 01-80010-35 | Outer Diameter 5 mm | In distribution |
| 01-80115-70 | Length 70 mm | In distribution |
| 01-80017-30 | Outer Diameter 9 mm | In distribution |
| 01-80129-65 | Length 65 mm | In distribution |
| 01-80135-40R | Length 40 mm | In distribution |
| 01-80110-40 | Length 40 mm | In distribution |
| 01-80045-35 | Length 35 mm | In distribution |
| 01-80028-60 | Outer Diameter 9 mm | In distribution |
| 01-80050-75 | Outer Diameter 8 mm | In distribution |
| 01-80122-55 | Length 55 mm | In distribution |
| 01-80014-50 | Outer Diameter 7 mm | In distribution |
| 01-80141-45 | Outer Diameter 5.5 mm | In distribution |
| IM80100-19 | Length 200 mm | In distribution |
| IM80188-03 | Length 40 mm | In distribution |
| 01-80143-45 | Outer Diameter 7 mm | In distribution |
| 01-80049-45 | Length 45 mm | In distribution |
| 01-80126-40 | Outer Diameter 5 mm | In distribution |
| 01-80129-45 | Length 45 mm | In distribution |
| 01-80010-25 | Length 25 mm | In distribution |
| 01-80139-35R | Length 35 mm | In distribution |
| 01-80147-70R | Outer Diameter 7 mm | In distribution |
| 01-80177-30 | Length 30 mm | In distribution |
| 01-85008-50R | Length 50 mm | In distribution |
| 01-80185-25 | Length 25 mm | In distribution |
| 01-80132-20 | Length 20 mm | In distribution |
| 01-80125-40 | Outer Diameter 9 mm | In distribution |
| 01-80046-50 | Outer Diameter 7 mm | In distribution |
| IM80022-11 | Length 80 mm | In distribution |
| 01-80123-50 | Length 50 mm | In distribution |
| 01-80133-55R | Outer Diameter 6 mm | In distribution |
| 01-80170-45R | Outer Diameter 6.5 mm | In distribution |
| 01-85010-35R | Length 35 mm | In distribution |
| 01-80164-5580 | Outer Diameter 5.5 mm | In distribution |
| 01-80068-100 | Outer Diameter 5.5 mm | In distribution |
| 01-80165-5580 | Length 80 mm | In distribution |
| 01-85008-45 | Length 45 mm | In distribution |
| 01-80130-35 | Outer Diameter 9 mm | In distribution |
| IM80102-16 | Outer Diameter 5.5 mm | In distribution |
| 01-80025-70 | Outer Diameter 5.5 mm | In distribution |
| 01-80164-55200 | Outer Diameter 5.5 mm | In distribution |
| 01-80137-35R | Outer Diameter 6 mm | In distribution |
| 01-80005-40 | Outer Diameter 5 mm | In distribution |
| 01-80044-30 | Length 30 mm | In distribution |
| 01-80025-60 | Outer Diameter 5.5 mm | In distribution |
| 01-80188-55 | Length 55 mm | In distribution |
| 01-80135-40 | Length 40 mm | In distribution |
| IM80189-04 | Outer Diameter 6 mm | In distribution |
| IM80190-02 | Length 35 mm | In distribution |
| 01-80164-55120 | Length 120 mm | In distribution |
| 01-80122-40 | Length 40 mm | In distribution |
| 01-80133-35R | Length 35 mm | In distribution |
| 01-80121-45 | Length 45 mm | In distribution |
| IM80020-05 | Length 50 mm | In distribution |
| 01-80142-30 | Length 30 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. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K143377 | 2015-02-12 |
| K133153 | 2014-05-14 |
| K123164 | 2013-02-15 |
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.