Endoskeleton® TA
12 Deg Lordotic, Rasp, Standard, 13mm
12manufacturers in China registered for this device type
43catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (4), Guangdong (3), Jiangsu (3). 4 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 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Shenzhen Xiazhifeng Electronic Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 25 |
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | HTR |
| Device type | Rasp |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| 510(k) | K080615 |
| Record published | 2016-12-15 |
| Record revised | 2022-06-10 (version 8) |
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 |
| Sizes | Angle 7 to 12 °; depth 21 to 27 mm; width 32 to 40 mm; height 8 to 16 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2112-7315 | Angle 12 ° | In distribution |
| 2106-7311 | Depth 27 mm | In distribution |
| 2106-7308 | Width 40 mm | In distribution |
| 2106-7214 | Angle 7 ° | In distribution |
| 2106-7216 | Angle 7 ° | In distribution |
| 2106-7309 | Depth 27 mm | In distribution |
| 2112-7212 | Depth 24 mm | In distribution |
| 2106-7210 | width(MLxAP), 36 x 24, mm | In distribution |
| 2112-7314 | Angle 12 ° | In distribution |
| 2106-7310 | Angle 7 ° | In distribution |
| 2106-7315 | Width 40 mm | In distribution |
| 2112-7211 | width(MLxAP), 36 x 24, mm | In distribution |
| 2112-7113 | Angle 12 ° | In distribution |
| 2112-7316 | Angle 12 ° | In distribution |
| 2112-7213 | width(MLxAP), 36 x 24, mm | In distribution |
| 2112-7210 | Angle 12 ° | In distribution |
| 2106-7111 | Angle 7 ° | In distribution |
| 2112-7115 | Width 32 mm | In distribution |
| 2106-7212 | Angle 7 ° | In distribution |
| 2112-7313 | width(MLxAP), 40 x 27, mm | In distribution |
| 2106-7312 | Depth 27 mm | In distribution |
| 2106-7108 | Depth 21 mm | In distribution |
| 2106-7314 | Depth 27 mm | In distribution |
| 2106-7110 | Depth 21 mm | In distribution |
| 2106-7211 | Angle 7 ° | In distribution |
| 2112-7110 | Depth 21 mm | In distribution |
| 2106-7209 | Depth 24 mm | In distribution |
| 2106-7116 | Depth 21 mm | In distribution |
| 2106-7114 | Angle 7 ° | In distribution |
| 2112-7215 | Angle 12 ° | In distribution |
| 2112-7111 | width(MLxAP), 32 x 21, mm | In distribution |
| 2106-7316 | Angle 7 ° | In distribution |
| 2112-7116 | Width 32 mm | In distribution |
| 2112-7216 | Angle 12 ° | In distribution |
| 2112-7312 | Depth 27 mm | In distribution |
| 2106-7208 | width(MLxAP), 36 x 24, mm | In distribution |
| 2106-7215 | Width 36 mm | In distribution |
| 2112-7214 | width(MLxAP), 36 x 24, mm | In distribution |
| 2112-7311 | Angle 12 ° | In distribution |
| 2112-7114 | Angle 12 ° | In distribution |
| 2106-7213 | Angle 7 ° | In distribution |
| 2112-7112 | Depth 21 mm | In distribution |
| 2112-7310 | Depth 27 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 240 |
| TiWAVE C Cervical Cage System | Kalitec Direct, LLC | 232 |
| Tranquil-C™ | Nexus Spine, L.L.C. | 158 |
| Calix Spinal Implant System | Xtant Medical Holdings, Inc. | 143 |
| Rasp | Medtronic Sofamor Danek, Inc. | 109 |
| Specials | Seaspine Orthopedics Corporation | 109 |
| Stryker | Avalign Technologies, Inc. | 105 |
| Endoskeleton® TAS | Medtronic Sofamor Danek, Inc. | 93 |
| Intervertebral Disc Preparation Instruments | Alphatec Spine, Inc. | 90 |
| Cambria | Seaspine Orthopedics Corporation | 85 |
| IdentiTi | Alphatec Spine, Inc. | 83 |
| Link Instruments – Rasps, compressors and broaches | Waldemar Link GmbH & Co. KG | 83 |
Showing 12 of 378. All products under Rasp
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.