OIC External Fixation System
3MM Self Tapping Half PIN, 15MM Thread Length, 110MM Long
17manufacturers in China registered for this device type
79catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (4), Zhejiang (3). 13 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 17. All 17 manufacturers in China registered for Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Record
| Listed by | Orthopaedic Implant Company, THE |
|---|---|
| FDA product code | KTT |
| Device type | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K171211 |
| Record published | 2018-07-31 |
| Record revised | 2023-04-04 (version 7) |
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, manufacturing date |
| Sizes | Outer diameter 2.4 to 11 mm; length 100 to 600 mm; lumen/inner diameter 5 to 11 mm; angle 0 to 90 ° |
| Distribution end date | 2021-05-26 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| XBR-11450 | Outer Diameter 11.0 mm | In distribution | |
| 01-EXF03 | In distribution | ||
| BTHP-0545M | Length 150 mm | In distribution | |
| EXF-C1105 | Lumen/Inner Diameter 5.0 mm | In distribution | |
| STHP-0430 | Outer Diameter 4.0 mm | In distribution | |
| STHP-0565L | Outer Diameter 5.0 mm | In distribution | |
| 01-EXF01 | In distribution | ||
| BLHP-0565L | Outer Diameter 5.0 mm | In distribution | |
| XBR-11200 | Length 200 mm | In distribution | |
| STHP-0535M | Length 150 mm | In distribution | |
| 01-EXF02 | In distribution | ||
| 01-EXF00 | In distribution | ||
| 01-EXF01 | In distribution | ||
| 01-EXF00 | In distribution | ||
| DR32-165C | Outer Diameter 3.2 mm | In distribution | |
| STHP-0555L | Outer Diameter 5.0 mm | In distribution | |
| XBR-11500 | Outer Diameter 11.0 mm | In distribution | |
| STHP-0545M | Outer Diameter 5.0 mm | In distribution | |
| 01-EXF04 | In distribution | ||
| BLHP-0430 | Outer Diameter 4.0 mm | In distribution | |
| XBR-11600 | Length 600 mm | In distribution | |
| STHP-0315M | Outer Diameter 3.0 mm | In distribution | |
| XBR-11500 | Length 500 mm | In distribution | |
| EXF-P30 | Angle 30 ° | In distribution | |
| STHP-0555L | Length 200 mm | In distribution | |
| BLHP-0535M | Length 150 mm | In distribution | |
| DR32-165C | Length 165 mm | In distribution | |
| XBR-11150 | Length 150 mm | In distribution | |
| DR40-200C | Outer Diameter 4.0 mm | In distribution | |
| XBR-11150 | Outer Diameter 11.0 mm | In distribution | |
| XBR-11300 | Outer Diameter 11.0 mm | In distribution | |
| XBR-11550 | Length 550 mm | In distribution | |
| XBR-11200 | Outer Diameter 11.0 mm | In distribution | |
| DR40-200C | Length 200 mm | In distribution | |
| BTHP-0535M | Outer Diameter 5.0 mm | In distribution | |
| STHP-0420 | Length 150 mm | In distribution | |
| XBR-11250 | Outer Diameter 11.0 mm | In distribution | |
| TFP-05250 | Outer Diameter 5.0 mm | In distribution | |
| BLHP-0555L | Length 200 mm | In distribution | |
| EXF-P30 | Outer Diameter 11.0 mm | In distribution | |
| EXF-C1105 | Lumen/Inner Diameter 11.0 mm | In distribution | |
| CAP-0525 | Lumen/Inner Diameter 5.0 mm | In distribution | |
| BTHP-0430 | Length 150 mm | In distribution | |
| XBR-11350 | Length 350 mm | In distribution | |
| 01-EXF04 | In distribution | ||
| XBR-11450 | Length 450 mm | In distribution | |
| TFP-05250 | Length 250 mm | In distribution | |
| BTHP-0555L | Outer Diameter 5.0 mm | In distribution | |
| XBR-11600 | Outer Diameter 11.0 mm | In distribution | |
| CAP-0525 | Lumen/Inner Diameter 5.0 mm | 10 | In distribution |
| EXF-MC08 | Lumen/Inner Diameter 5.0 mm | In distribution | |
| BLHP-0420 | Length 150 mm | In distribution | |
| 01-EXF05 | Lumen/Inner Diameter 10 mm | In distribution | |
| BLHP-0545M | Outer Diameter 5.0 mm | In distribution | |
| STHP-0545M | Length 150 mm | In distribution | |
| STHP-0420 | Outer Diameter 4.0 mm | In distribution | |
| BTHP-0565L | Length 200 mm | In distribution | |
| 01-EXF05 | Lumen/Inner Diameter 10 mm | In distribution | |
| STHP-0565L | Length 200 mm | In distribution | |
| XBR-11400 | Length 400 mm | In distribution | |
| STHP-0535M | Outer Diameter 5.0 mm | In distribution | |
| XBR-11350 | Outer Diameter 11.0 mm | In distribution | |
| EXF-MC05 | Lumen/Inner Diameter 5.0 mm | In distribution | |
| STHP-0430 | Length 150 mm | In distribution | |
| STHP-0320S | Outer Diameter 3.0 mm | In distribution | |
| BTHP-0420 | Outer Diameter 4.0 mm | In distribution | |
| DR24-140C | Outer Diameter 2.4 mm | In distribution | |
| EXF-P00 | Angle 0 ° | In distribution | |
| EXF-MC05 | Lumen/Inner Diameter 5.0 mm | In distribution | |
| XBR-11100 | Outer Diameter 11.0 mm | In distribution | |
| 01-EXF03 | In distribution | ||
| 01-EXF02 | In distribution | ||
| XBR-11250 | Length 250 mm | In distribution | |
| XBR-11300 | Length 300 mm | In distribution | |
| EXF-P90 | Angle 90 ° | In distribution | |
| XBR-11400 | Outer Diameter 11.0 mm | In distribution | |
| EXF-P00 | Outer Diameter 11.0 mm | In distribution | |
| STHP-0315M | Outer Diameter 3.0 mm | Withdrawn | |
| DR24-140C | Outer Diameter 3.2 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Smart Correction | Wishbone Medical Inc. | 1,534 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Synthes Gmbh | 880 |
| LCP | Synthes Gmbh | 355 |
| Orthex External Fixation System | Orthopediatrics, Corp | 353 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Sterilmed, Inc. | 325 |
| CHS | Smith & Nephew, Inc. | 321 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Stryker Sustainability Solutions | 277 |
| Hoffmann | Stryker GmbH | 239 |
| Orthex | Orthopediatrics, Corp | 231 |
| Orthex | Vilex IN Tennessee, Inc. | 221 |
| Omega | Stryker GmbH | 212 |
| eZ-Fix | Orthopediatrics, Corp | 207 |
Showing 12 of 530. All products under Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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.