Fitbone®
Control Set for retracting the intramedullary lengthening nail
17manufacturers in China registered for this device type
174catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 17. All 17 manufacturers in China registered for Rod, Fixation, Intramedullary And Accessories
Record
| Listed by | Wittenstein Intens GmbH, Germany |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| 510(k) | K163368 |
| Record published | 2017-12-12 |
| Record revised | 2025-02-06 (version 9) |
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, serial number |
| Sizes | Outer diameter 8 to 16 mm; length 20 to 700 mm; lumen/inner diameter 8 to 16 mm |
| Distribution end date | 2022-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TUBE T12/11-M | Lumen/Inner Diameter 11 mm | Withdrawn |
| LOSC D4.5 L40 LT | Length 40 mm | Withdrawn |
| FAKN L400 | Withdrawn | |
| TUBE T12/11-XL | Lumen/Inner Diameter 11 mm | Withdrawn |
| TUBE T16/15-M | Lumen/Inner Diameter 15 mm | Withdrawn |
| DUMM TAA1140-T-205 | Outer Diameter 11 mm | Withdrawn |
| SESC | Withdrawn | |
| REAM D13.5 L200 L700 RD | Outer Diameter 13.5 mm | Withdrawn |
| TUBE T12/10-L | Lumen/Inner Diameter 10 mm | Withdrawn |
| TUBE T14/13-S | Lumen/Inner Diameter 13 mm | Withdrawn |
| REAM D12.0 L200 L480 RD | Outer Diameter 12 mm | Withdrawn |
| CONE C13++ | Outer Diameter 13 mm | Withdrawn |
| TAA0960-T-220 | Outer Diameter 9 mm | Withdrawn |
| CEl 115V | Withdrawn | |
| TAA1140-F-205 | Outer Diameter 11 mm | Withdrawn |
| CONE C15++ | Outer Diameter 15 mm | Withdrawn |
| TUBE T14/13-L | Lumen/Inner Diameter 13 mm | Withdrawn |
| TUBE T16/15-L | Lumen/Inner Diameter 15 mm | Withdrawn |
| LOSC D4.5 L20 ST | Length 20 mm | Withdrawn |
| LOSC D4.5 L35 ST | Length 35 mm | Withdrawn |
| LOSC D4.5 L50 ST | Length 50 mm | Withdrawn |
| LOSC D4.5 L75 LT | Length 75 mm | Withdrawn |
| CONE C13 | Outer Diameter 13 mm | Withdrawn |
| STRE TAA1180 | Withdrawn | |
| CLAM | Withdrawn | |
| REAM D13.5 L200 L480 RD | Outer Diameter 13.5 mm | Withdrawn |
| TUBE T12/10-S | Lumen/Inner Diameter 10 mm | Withdrawn |
| Reamer Tray L700 | Withdrawn | |
| REAM D11.0 L200 L480 RD | Outer Diameter 11 mm | Withdrawn |
| TUBE T15/14-XL | Lumen/Inner Diameter 14 mm | Withdrawn |
| Upgrade Reamer Tray SAA and TAA13 L480 | Withdrawn | |
| SCDR SW3.5 CA | Withdrawn | |
| REAM D10.0 L100 L700 FC | Outer Diameter 10 mm | Withdrawn |
| REAM D13.0 L100 L480 FC | Outer Diameter 13 mm | Withdrawn |
| COSI CS15-13 | Outer Diameter 12 mm | Withdrawn |
| DUMM TAA1180-T-245 | Outer Diameter 11 mm | Withdrawn |
| CONE C15+ | Outer Diameter 15 mm | Withdrawn |
| TUBE T12/09-XL | Lumen/Inner Diameter 9 mm | Withdrawn |
| REAM D15.0 L200 L700 RD | Outer Diameter 15 mm | Withdrawn |
| LOSC D4.5 L25 ST | Length 25 mm | Withdrawn |
| REAM D13.0 L200 L700 RD | Outer Diameter 13 mm | Withdrawn |
| TEPI D4.5 | Withdrawn | |
| LOSC D4.5 L20 LT | Length 20 mm | Withdrawn |
| REAM D11.0 L100 L700 FC | Outer Diameter 11 mm | Withdrawn |
| DEGA | Withdrawn | |
| REAM D10.0 L100 L480 FC | Outer Diameter 10 mm | Withdrawn |
| REAM D10.5 L200 L480 RD | Outer Diameter 10.5 mm | Withdrawn |
| REAM D12.0 L100 L700 FC | Outer Diameter 12 mm | Withdrawn |
| TAA1140-T-205 | Outer Diameter 11 mm | Withdrawn |
| STRE TAA1140 | Withdrawn | |
| TATO | Withdrawn | |
| REAM D14.0 L200 L700 RD | Outer Diameter 14 mm | Withdrawn |
| CONE C13 RP | Outer Diameter 13 mm | Withdrawn |
| TUSI TS15 | Lumen/Inner Diameter 16 mm | Withdrawn |
| DUMM TAA1140-F-205 | Outer Diameter 11 mm | Withdrawn |
| CLNU TAA | Withdrawn | |
| Instrument Tray TAA09 | Withdrawn | |
| TROC D4.5 | Withdrawn | |
| TUBE T13/12-L | Lumen/Inner Diameter 12 mm | Withdrawn |
| REAM D12.0 L200 L700 RD | Outer Diameter 12 mm | Withdrawn |
| FABO M6 L9 | Withdrawn | |
| TUBE T12/09-S | Lumen/Inner Diameter 9 mm | Withdrawn |
| TAA0940-T-200 | Outer Diameter 9 mm | Withdrawn |
| REAM D12.5 L200 L700 RD | Outer Diameter 12.5 mm | Withdrawn |
| OURI TAA | Withdrawn | |
| LOSC D4.5 L60 LT | Length 60 mm | Withdrawn |
| LOSC D4.5 L55 LT | Length 55 mm | Withdrawn |
| Upgrade Tube-System SAA | Withdrawn | |
| Tube-System TAA | Withdrawn | |
| ME Tray TAA09/11 loan | Withdrawn | |
| TUBE T12/08-XL | Lumen/Inner Diameter 8 mm | Withdrawn |
| REAM D12.5 L200 L480 RD | Outer Diameter 12.5 mm | Withdrawn |
| RCS 120V -A | Withdrawn | |
| COBO TAA | Withdrawn | |
| SPHO TAA | Withdrawn | |
| REAM D11.5 L200 L480 RD | Outer Diameter 11.5 mm | Withdrawn |
| FABO M4 L400 | Withdrawn | |
| LOSC D4.5 L80 LT | Length 80 mm | Withdrawn |
| REAM D13.0 L200 L480 RD | Outer Diameter 13 mm | Withdrawn |
| TUBE T14/13-XL | Lumen/Inner Diameter 13 mm | Withdrawn |
| LOSC D4.5 L50 LT | Length 50 mm | Withdrawn |
| REAM D13.0 L100 L700 FC | Outer Diameter 13 mm | Withdrawn |
| STRE TAA1160 | Withdrawn | |
| DRSL D4.5 BL | Withdrawn | |
| DUMM TAA1160-T-225 | Outer Diameter 11 mm | Withdrawn |
| REAM D12.0 L100 L480 FC | Outer Diameter 12 mm | Withdrawn |
| SCHO M2 L325 | Withdrawn | |
| CONE C14 | Outer Diameter 14 mm | Withdrawn |
| REAM D9.0 L200 L700 RD | Outer Diameter 9 mm | Withdrawn |
| TUBE T12/11-S | Lumen/Inner Diameter 11 mm | Withdrawn |
| CEl 120V | Withdrawn | |
| OEWR SW14/17 | Withdrawn | |
| DUMM TAA1160-F-225 | Outer Diameter 11 mm | Withdrawn |
| DUMM TAA1380-F-245 | Outer Diameter 13 mm | Withdrawn |
| WICA 90° | Withdrawn | |
| TAA1160-T-225 | Outer Diameter 11 mm | Withdrawn |
| KIWI D3 L280 | Withdrawn | |
| TAA1180-F-245 | Outer Diameter 11 mm | Withdrawn |
| LOSC D4.5 L25 LT | Length 25 mm | Withdrawn |
| TUBE T13/12-M | Lumen/Inner Diameter 12 mm | Withdrawn |
| CS 120V -A | Withdrawn | |
| TUBE T14/13-M | Outer Diameter 14 mm | Withdrawn |
| CONE C13+ | Outer Diameter 13 mm | Withdrawn |
| TUSI TS12 | Lumen/Inner Diameter 13 mm | Withdrawn |
| REAM D8.0 L200 L480 RD | Length 480 mm | Withdrawn |
| Extractor Tray TAA | Withdrawn | |
| REAM D10.0 L200 L480 RD | Outer Diameter 10 mm | Withdrawn |
| TUBE T12/08-L | Lumen/Inner Diameter 8 mm | Withdrawn |
| REAM D15.0 L200 L480 RD | Outer Diameter 15 mm | Withdrawn |
| Screw Box | Withdrawn | |
| LOSC D4.5 L65 LT | Length 65 mm | Withdrawn |
| LOSC D4.5 L70 LT | Length 70 mm | Withdrawn |
| DUMM TAA1180-F-245 | Outer Diameter 11 mm | Withdrawn |
| REAM D11.5 L200 L700 RD | Outer Diameter 11.5 mm | Withdrawn |
| CONE C11 | Outer Diameter 11 mm | Withdrawn |
| TUSI TS14 | Lumen/Inner Diameter 15 mm | Withdrawn |
| ME Tray TAA13 loan | Withdrawn | |
| REAM D14.0 L200 L480 RD | Outer Diameter 14 mm | Withdrawn |
| LOSC D4.5 L40 ST | Length 40 mm | Withdrawn |
| DRBI D4.5 L300 CO | Withdrawn | |
| Transmitter | Withdrawn | |
| Instrument Tray TAA13 | Withdrawn | |
| TUBE T13/12-XL | Lumen/Inner Diameter 12 mm | Withdrawn |
| THAN | Withdrawn | |
| SCDR SW3.5 | Withdrawn | |
| TUBE T16/15-XL | Lumen/Inner Diameter 15 mm | Withdrawn |
| REAM D9.0 L200 L480 RD | Outer Diameter 9 mm | Withdrawn |
| COSI CS12-11 | Outer Diameter 10 mm | Withdrawn |
| TUBE T15/14-L | Lumen/Inner Diameter 14 mm | Withdrawn |
| REAM D9.0 L100 L480 FC | Length 480 mm | Withdrawn |
| TROC D4.5 TH | Withdrawn | |
| PLIE FS | Withdrawn | |
| IMSL | Withdrawn | |
| GRID | Withdrawn | |
| LOSC D4.5 L45 ST | Length 45 mm | Withdrawn |
| TAA0960-F-220 | Outer Diameter 9 mm | Withdrawn |
| DRBI D4.5 L300 | Withdrawn | |
| TUBE T15/14-M | Lumen/Inner Diameter 14 mm | Withdrawn |
| Reamer Tray TAA L480 | Withdrawn | |
| TADE 45°/90° | Withdrawn | |
| REAM D9.0 L100 L700 FC | Outer Diameter 9 mm | Withdrawn |
| REAM D10.5 L200 L700 RD | Outer Diameter 10.5 mm | Withdrawn |
| TUBE T12/08-S | Lumen/Inner Diameter 8 mm | Withdrawn |
| TUSI TS13 | Lumen/Inner Diameter 14 mm | Withdrawn |
| REAM D8.0 L200 L700 RD | Outer Diameter 8 mm | Withdrawn |
| REAM D11.0 L100 L480 FC | Outer Diameter 11 mm | Withdrawn |
| DRGU TAA | Withdrawn | |
| TAA1160-F-225 | Outer Diameter 11 mm | Withdrawn |
| DRSL D8.0 GR | Withdrawn | |
| Instrument Tray TAA | Withdrawn | |
| LOSC D4.5 L35 LT | Length 35 mm | Withdrawn |
| TUBE T12/10-XL | Lumen/Inner Diameter 10 mm | Withdrawn |
| CONE C15 | Outer Diameter 15 mm | Withdrawn |
| TUBE T12/11-L | Lumen/Inner Diameter 11 mm | Withdrawn |
| TAA1180-T-245 | Length 245 mm | Withdrawn |
| REAM D11.0 L200 L700 RD | Outer Diameter 11 mm | Withdrawn |
| LOSC D4.5 L45 LT | Length 45 mm | Withdrawn |
| CS 115V -A | Withdrawn | |
| Receiver | Withdrawn | |
| TUBE T13/12-S | Lumen/Inner Diameter 12 mm | Withdrawn |
| TUBE T12/09-L | Lumen/Inner Diameter 9 mm | Withdrawn |
| TUBE T12/10-M | Lumen/Inner Diameter 10 mm | Withdrawn |
| REAM D10.0 L200 L700 RD | Outer Diameter 10 mm | Withdrawn |
| Receiver | Withdrawn | |
| TAA1380-F-245 | Outer Diameter 13 mm | Withdrawn |
| TAA0940-F-200 | Outer Diameter 9 mm | Withdrawn |
| TUSI TS11 | Lumen/Inner Diameter 12 mm | Withdrawn |
| CONE C12 | Outer Diameter 12 mm | Withdrawn |
| DRGU BLSC TAA11 | Withdrawn | |
| LOSC D4.5 L30 ST | Length 30 mm | Withdrawn |
| General Tray | Withdrawn | |
| TUBE T12/08-M | Lumen/Inner Diameter 08 mm | Withdrawn |
| TUBE T12/09-M | Lumen/Inner Diameter 09 mm | Withdrawn |
| LOSC D4.5 L30 LT | Length 30 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| T2 | Stryker GmbH | 1,373 |
| Autobahn | Globus Medical, Inc. | 1,258 |
| Gamma | Stryker GmbH | 1,120 |
| Summa Orthopaedics Femur Nail System | Jeil Medical Corporation | 742 |
| Arix Femur Nail System | Jeil Medical Corporation | 742 |
| Orthofix | Orthofix SRL | 721 |
| Rod, Fixation, Intramedullary And Accessories | Synthes Gmbh | 715 |
| Trigen | Smith & Nephew, Inc. | 681 |
| Arthrex® | Arthrex, Inc. | 665 |
| Precice® Intramedullary Limb Lengthening System | NuVasive Specialized Orthopedics, Inc. | 596 |
| Apex | Orthoxel Designated Activity Company | 569 |
| Natural Nail® | Zimmer, Inc. | 552 |
Showing 12 of 2,207. All products under Rod, Fixation, Intramedullary And Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203399 | 2021-02-17 |
| K163368 | 2017-01-26 |
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.