Equinoxe
Humeral Augmented Tray Trial, +0 Lateralized, Right, Captured Screw
21manufacturers in China registered for this device type
371catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (3), Zhejiang (2). 11 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 |
| 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 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Guangzhou Clean Medical Products Manufacturing Corp | Guangzhou | Guangdong | Contract manufacturer | 5 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Showing 12 of 21. All 21 manufacturers in China registered for Template
Record
| Listed by | Exactech, Inc., United States |
|---|---|
| FDA product code | HWT |
| Device type | Template |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-09-19 |
| Record revised | 2023-10-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Sizes | Outer diameter 6 to 53 mm; angle 8 to 135 °; height 2.5 to 75 mm; lumen/inner diameter 17.5 to 33.5 mm; length 175 to 215 mm |
| Distribution end date | 2024-09-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 311-30-53 | EXTRA SHORT | In distribution |
| 305-01-12 | LEFT | In distribution |
| SPI-010447 | In distribution | |
| 321-10-10 | Height 10 mm | In distribution |
| 305-02-07 | RIGHT | In distribution |
| SPI-044487 | In distribution | |
| 325-44-10 | Constrained | In distribution |
| 313-01-41 | Outer Diameter 41 mm | In distribution |
| 311-21-53 | SHORT | In distribution |
| 321-42-27 | Outer Diameter 42 mm | In distribution |
| 321-24-22 | In distribution | |
| 319-11-50 | BETA | In distribution |
| 309-05-26 | Lumen/Inner Diameter 26.5 mm | In distribution |
| 321-31-40 | Outer Diameter 40 mm | In distribution |
| 309-12-05 | LARGE | In distribution |
| 321-24-12 | In distribution | |
| 321-46-03 | Outer Diameter 46 mm | In distribution |
| 311-12-41 | TALL | In distribution |
| 305-02-10 | Outer Diameter 9.5 mm | In distribution |
| 319-11-53 | Height 20 mm | In distribution |
| 321-12-46 | Outer Diameter 46 mm | In distribution |
| 321-36-00 | Outer Diameter 36 mm | In distribution |
| 315-63-24 | In distribution | |
| 321-04-42 | Outer Diameter 42 mm | In distribution |
| 315-04-33 | MEDIUM | In distribution |
| 315-12-25 | LEFT | In distribution |
| 325-46-13 | Constrained | In distribution |
| SPI-043408 | In distribution | |
| 321-24-10 | In distribution | |
| SPI-045895 | Size: 42mm, +2.5 | In distribution |
| 315-63-34 | In distribution | |
| 315-04-23 | LEFT | In distribution |
| 311-11-47 | SHORT | In distribution |
| 321-24-01 | In distribution | |
| 319-10-50 | Outer Diameter 50 mm | In distribution |
| 321-13-10 | In distribution | |
| 311-01-38 | Outer Diameter 38 mm | In distribution |
| 309-05-20 | Lumen/Inner Diameter 20.5 mm | In distribution |
| 315-53-04 | LARGE | In distribution |
| 315-68-23 | In distribution | |
| 321-95-00-01 | In distribution | |
| 321-46-27 | Height 7.5 mm | In distribution |
| 321-42-23 | Outer Diameter 42 mm | In distribution |
| 313-01-38 | Outer Diameter 38 mm | In distribution |
| 315-68-25 | In distribution | |
| 313-01-41 | Outer Diameter 41 mm | In distribution |
| 311-31-50 | SHORT | In distribution |
| 301-25-00 | 0mm | In distribution |
| 325-36-10 | +0mm | In distribution |
| 311-00-53 | EXTRA SHORT | In distribution |
| 315-12-32 | Angle 8 ° | In distribution |
| 321-13-05 | In distribution | |
| 319-10-38 | EXTRA SHORT | In distribution |
| 321-42-13 | Outer Diameter 42 mm | In distribution |
| 311-31-53 | Outer Diameter 53 mm | In distribution |
| 315-63-23 | In distribution | |
| SPI-045896 | Size: 42mm, +0 | In distribution |
| 321-38-03 | Outer Diameter 38 mm | In distribution |
| 315-66-33 | In distribution | |
| 305-95-21 | In distribution | |
| 305-22-11 | Outer Diameter 10.5 mm | In distribution |
| 315-06-24 | LARGE | In distribution |
| 311-12-38 | Outer Diameter 38 mm | In distribution |
| 315-02-02 | SMALL | In distribution |
| 321-42-00 | Height 0 mm | In distribution |
| 315-73-03 | In distribution | |
| 319-11-41 | Outer Diameter 41 mm | In distribution |
| 319-11-47 | Height 18 mm | In distribution |
| 321-38-27 | Height 7.5 mm | In distribution |
| 325-44-00 | 44mm | In distribution |
| 313-95-00-01 | 25mm X-ray template | In distribution |
| 321-14-05 | Height 5 mm | In distribution |
| 315-66-25 | In distribution | |
| 321-95-00-42 | 42mm x-ray template | In distribution |
| 321-32-40 | Outer Diameter 40 mm | In distribution |
| 315-12-03 | MEDIUM | In distribution |
| 321-01-09 | Outer Diameter 9 mm | In distribution |
| 309-05-31 | Lumen/Inner Diameter 31.5 mm | In distribution |
| 313-01-53 | Outer Diameter 53 mm | In distribution |
| 313-01-44 | Outer Diameter 44 mm | In distribution |
| 311-95-20-50 | 50-53mm Outer Diameter | In distribution |
| 315-04-32 | SMALL | In distribution |
| 315-68-32 | In distribution | |
| 313-01-47 | Outer Diameter 47 mm | In distribution |
| 321-40-00 | Outer Diameter 40 mm | In distribution |
| 311-00-50 | Outer Diameter 50 mm | In distribution |
| 321-10-11 | Height 10 mm | In distribution |
| 309-05-22 | Lumen/Inner Diameter 22.5 mm | In distribution |
| SPI-010445 | In distribution | |
| 321-14-10 | Height 10 mm | In distribution |
| 315-63-32 | In distribution | |
| 321-01-08 | Outer Diameter 8 mm | In distribution |
| 309-01-07 | Outer Diameter 7 mm | In distribution |
| SPI-045894 | Size: 42mm, +7.5 | In distribution |
| 309-10-05 | LARGE | In distribution |
| 309-05-17 | Lumen/Inner Diameter 17.5 mm | In distribution |
| 321-42-10 | Outer Diameter 42 mm | In distribution |
| 321-38-20 | Outer Diameter 38 mm | In distribution |
| 321-42-03 | Outer Diameter 42 mm | In distribution |
| 311-02-44 | Outer Diameter 44 mm | In distribution |
| SPI-043405 | In distribution | |
| 315-53-02 | SMALL | In distribution |
| 321-40-10 | Outer Diameter 40 mm | In distribution |
| SPI-045899 | Size: 40mm, +2.5 | In distribution |
| 311-03-50 | EXPANDED | In distribution |
| 321-03-08 | Length 215 mm | In distribution |
| 309-08-12 | Height 12.5 mm | In distribution |
| 315-04-35 | EXTRA LARGE | In distribution |
| 315-68-33 | In distribution | |
| 350-95-00 | In distribution | |
| 325-42-13 | Constrained | In distribution |
| 313-95-00 | In distribution | |
| SPI-044489 | In distribution | |
| 315-12-33 | Angle 8 ° | In distribution |
| SPI-010425 | In distribution | |
| 321-36-13 | Outer Diameter 36 mm | In distribution |
| 321-01-07 | Outer Diameter 7 mm | In distribution |
| 305-21-11 | Outer Diameter 10.5 mm | In distribution |
| 311-30-41 | EXTRA SHORT | In distribution |
| 325-40-00 | 40mm | In distribution |
| 321-38-25 | Outer Diameter 38 mm | In distribution |
| 309-01-11 | Outer Diameter 11 mm | In distribution |
| 321-02-10 | Outer Diameter 10 mm | In distribution |
| 315-06-32 | RIGHT | In distribution |
| 311-22-38 | Outer Diameter 38 mm | In distribution |
| 305-01-07 | Outer Diameter 7 mm | In distribution |
| 315-01-02 | SMALL | In distribution |
| 315-95-00 | In distribution | |
| 315-12-34 | RIGHT | In distribution |
| 311-31-47 | SHORT | In distribution |
| 311-95-20-99 | In distribution | |
| 321-00-00 | In distribution | |
| 325-38-10 | Constrained | In distribution |
| 315-63-22 | In distribution | |
| 315-12-22 | Angle 8 ° | In distribution |
| SPI-045897 | Size: 40mm, +7.5 | In distribution |
| 311-00-47 | Outer Diameter 47 mm | In distribution |
| 315-02-03 | MEDIUM | In distribution |
| 315-12-04 | LARGE | In distribution |
| 307-95-00 | In distribution | |
| 311-30-50 | Outer Diameter 50 mm | In distribution |
| 311-12-47 | Outer Diameter 47 mm | In distribution |
| 311-03-47 | Outer Diameter 47 mm | In distribution |
| 315-04-22 | SMALL | In distribution |
| 311-31-41 | SHORT | In distribution |
| 309-05-18 | Lumen/Inner Diameter 18.5 mm | In distribution |
| SPI-044486 | In distribution | |
| 321-01-12 | Outer Diameter 12 mm | In distribution |
| SPI-044491 | In distribution | |
| 301-95-00 | In distribution | |
| 315-06-35 | EXTRA LARGE | In distribution |
| 319-10-44 | EXTRA SHORT | In distribution |
| 311-31-44 | Outer Diameter 44 mm | In distribution |
| 309-10-75 | Height 75 mm | In distribution |
| 321-01-42 | Outer Diameter 42 mm | In distribution |
| SPI-001385 | In distribution | |
| 311-95-20-44 | 44-47mm Outer Diameter | In distribution |
| 315-06-33 | RIGHT | In distribution |
| 321-38-00 | Height 0 mm | In distribution |
| 309-13-50 | In distribution | |
| 321-95-00-46 | 46mm x-ray template | In distribution |
| 309-05-27 | Lumen/Inner Diameter 27.5 mm | In distribution |
| 305-21-13 | LEFT | In distribution |
| 321-01-13 | Outer Diameter 13 mm | In distribution |
| 331-50-45 | 4.5mm offset | In distribution |
| 321-42-25 | Outer Diameter 42 mm | In distribution |
| 321-10-05 | Height 5 mm | In distribution |
| 311-00-44 | EXTRA SHORT | In distribution |
| 315-63-25 | In distribution | |
| SPI-045891 | Size: 42mm, +7.5 | In distribution |
| 325-36-03 | 36mm | In distribution |
| 315-73-04 | In distribution | |
| 315-66-32 | In distribution | |
| 311-22-41 | TALL | In distribution |
| 309-10-00 | Height 0 mm | In distribution |
| SPI-001406 | In distribution | |
| 325-40-03 | 40mm | In distribution |
| 325-44-03 | 44mm | In distribution |
| 311-11-38 | Outer Diameter 38 mm | In distribution |
| 325-44-13 | +2.5mm | In distribution |
| 309-08-00 | EXTRA SMALL | In distribution |
| 311-01-47 | Outer Diameter 47 mm | In distribution |
| 321-06-38 | Outer Diameter 38 mm | In distribution |
| 315-06-34 | RIGHT | In distribution |
| 311-02-38 | Outer Diameter 38 mm | In distribution |
| 321-46-25 | Outer Diameter 46 mm | In distribution |
| 311-95-00 | In distribution | |
| SPI-044488 | In distribution | |
| 321-01-15 | Outer Diameter 15 mm | In distribution |
| 325-46-00 | 46mm | In distribution |
| 311-21-41 | Outer Diameter 41 mm | In distribution |
| 311-31-38 | Outer Diameter 38 mm | In distribution |
| 311-11-41 | SHORT | In distribution |
| 309-10-25 | Height 25 mm | In distribution |
| 311-01-53 | SHORT | In distribution |
| 321-46-13 | Outer Diameter 46 mm | In distribution |
| 321-01-11 | Outer Diameter 11 mm | In distribution |
| SPI-045900 | Size: 40mm, +0 | In distribution |
| 315-66-24 | In distribution | |
| 305-21-07 | LEFT | In distribution |
| SPI-001390 | In distribution | |
| 319-10-47 | EXTRA SHORT | In distribution |
| 321-24-02 | In distribution | |
| 305-95-21-07 | Outer Diameter 6.5 mm | In distribution |
| 309-13-25 | In distribution | |
| 309-09-12 | SMALL | In distribution |
| SPI-043411 | In distribution | |
| 321-40-13 | Height 2.5 mm | In distribution |
| 309-10-50 | Height 50 mm | In distribution |
| 311-02-47 | TALL | In distribution |
| 315-68-35 | In distribution | |
| 321-14-00 | Height 0 mm | In distribution |
| 305-01-10 | LEFT | In distribution |
| 313-01-50 | Outer Diameter 50 mm | In distribution |
| 309-12-00 | Height 12.5 mm | In distribution |
| 315-68-34 | In distribution | |
| 321-46-23 | Outer Diameter 46 mm | In distribution |
| 321-02-08 | Outer Diameter 8 mm | In distribution |
| 313-01-50 | Outer Diameter 50 mm | In distribution |
| SPI-007906 | In distribution | |
| 311-22-50 | TALL | In distribution |
| 321-24-00 | In distribution | |
| 311-02-53 | Outer Diameter 53 mm | In distribution |
| 319-10-41 | EXTRA SHORT | In distribution |
| 315-68-22 | In distribution | |
| 321-36-03 | Height 2.5 mm | In distribution |
| 305-21-09 | Outer Diameter 8.5 mm | In distribution |
| 325-38-00 | +0mm | In distribution |
| 309-10-10 | Height 0 mm | In distribution |
| 315-12-05 | EXTRA LARGE | In distribution |
| 321-11-10 | Outer Diameter 10 mm | In distribution |
| 321-08-42 | Outer Diameter 42 mm | In distribution |
| SPI-001391 | In distribution | |
| 321-01-17 | Outer Diameter 17 mm | In distribution |
| 321-31-36 | Outer Diameter 36 mm | In distribution |
| 309-05-30 | Lumen/Inner Diameter 30.5 mm | In distribution |
| SPI-001346 | In distribution | |
| 309-01-08 | Outer Diameter 8 mm | In distribution |
| 309-05-28 | Lumen/Inner Diameter 28.5 mm | In distribution |
| 321-24-11 | In distribution | |
| 321-42-20 | Outer Diameter 42 mm | In distribution |
| 315-01-04 | LARGE | In distribution |
| 321-38-10 | Outer Diameter 38 mm | In distribution |
| 311-12-53 | TALL | In distribution |
| 321-46-10 | Height 0 mm | In distribution |
| 325-40-10 | Angle 135 ° | In distribution |
| 313-01-38 | Outer Diameter 38 mm | In distribution |
| 315-12-02 | SMALL | In distribution |
| 311-22-47 | Outer Diameter 47 mm | In distribution |
| 313-01-53 | Outer Diameter 53 mm | In distribution |
Showing 250 of 300 catalogue numbers.
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| Evolution® | Microport Orthopedics Inc. | 966 |
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Showing 12 of 2,940. All products under Template
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.