ACE
infinity TRICAM 6POINT RATCHET SPLINE DRIVER 21.8MM LONG SS 17-4 (H900)
9manufacturers in China registered for this device type
64catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Zhejiang (2), Shanghai (1). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Jiangsu Kersen Medical Instrument Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 3 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Ace Surgical Supply Co., Inc., United States |
|---|---|
| FDA product code | HWR |
| Device type | Driver, Prosthesis |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2019-10-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: No special storage conditions required |
| Sizes | Length 9 to 72 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20157502 | Length 26 mm | In distribution |
| 04977001 | Length 25 mm | In distribution |
| 20953702 | Length 30 mm | In distribution |
| 04977901 | Length 27 mm | In distribution |
| 20151511 | Length 13 mm | In distribution |
| 20953001 | Length 24 mm | In distribution |
| 20151501 | Length 17 mm | In distribution |
| 20158502 | Length 72 mm | In distribution |
| 04153501 | Length 18 mm | In distribution |
| 04151701 | Length 22 mm | In distribution |
| 20153501 | Length 17 mm | In distribution |
| 04965501 | Length 21 mm | In distribution |
| 05560201 | Length 12 mm | In distribution |
| 20953501 | Length 24 mm | In distribution |
| 05560501 | Length 12 mm | In distribution |
| 05560401 | Length 12 mm | In distribution |
| 20156001 | Length 17 mm | In distribution |
| 45485501 | In distribution | |
| 04151001 | Length 17 mm | In distribution |
| 20150011S | In distribution | |
| 20156702 | Length 14 mm | In distribution |
| 20953701 | Length 24 mm | In distribution |
| 05560301 | Length 12 mm | In distribution |
| 20151002 | Length 22 mm | In distribution |
| 20159502 | Length 24 mm | In distribution |
| 04977701 | Length 27 mm | In distribution |
| 04966301 | Length 25 mm | In distribution |
| 20153001 | Length 17 mm | In distribution |
| 20154002 | Length 20 mm | In distribution |
| 11151911 | In distribution | |
| 45417501 | In distribution | |
| 20155811 | Length 13 mm | In distribution |
| 20156502 | Length 9 mm | In distribution |
| 20150011 | In distribution | |
| 20156501 | Length 17.7 mm | In distribution |
| 20151512 | Length 18 mm | In distribution |
| 20156901 | Length 10 mm | In distribution |
| 20953002 | Length 30 mm | In distribution |
| 04974111 | Length 15 mm | In distribution |
| 20155901 | Length 15 mm | In distribution |
| 04965001 | Length 22 mm | In distribution |
| 20156002 | Length 15 mm | In distribution |
| 04152101 | Length 21 mm | In distribution |
| 20953502 | Length 30 mm | In distribution |
| 04151002 | Length 23 mm | In distribution |
| 45415201 | In distribution | |
| 04977501 | Length 17 mm | In distribution |
| 20159501 | Length 16 mm | In distribution |
| 20158501 | Length 26 mm | In distribution |
| 20151502 | Length 21.8 mm | In distribution |
| 11974111 | In distribution | |
| 20155902 | Length 19 mm | In distribution |
| 13156002 | Length 22 mm | In distribution |
| 04156001 | Length 19 mm | In distribution |
| 20154001 | Length 17 mm | In distribution |
| 20156902 | Length 14 mm | In distribution |
| 20151001 | Length 17 mm | In distribution |
| 45481301 | In distribution | |
| 20151911 | Length 15 mm | In distribution |
| 13151701 | In distribution | |
| 04154001 | Length 17 mm | In distribution |
| 20155812 | Length 16 mm | In distribution |
| 13156001 | Length 17 mm | In distribution |
| 20156701 | Length 10 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Driver, Prosthesis | Depuy Spine, Inc. | 270 |
| Expedium | Medos International Sàrl | 54 |
| Moss | Depuy Spine, Inc. | 33 |
| Acumed | Acumed LLC | 24 |
| Streamline TL Spinal Fixation System | Pioneer Surgical Technology, Inc. | 23 |
| U2 Total Knee System | United Orthopedic Corp. | 23 |
| Driver, Prosthesis | Zimmer, Inc. | 22 |
| Viper | Depuy Spine, Inc. | 21 |
| X-Mesh | Depuy Spine, Inc. | 20 |
| Driver, Prosthesis | Depuy (Ireland) | 18 |
| Invictus | Alphatec Spine, Inc. | 18 |
| General Instruments | Alphatec Spine, Inc. | 18 |
Showing 12 of 390. All products under Driver, Prosthesis
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.