Irix-C Cervical Integrated Fusion System
Specialty 11MM Irix-C Parallel Rasp Assy W/O Stops
12manufacturers in China registered for this device type
44catalogue 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 | Xtant Medical Holdings, Inc., United States |
|---|---|
| FDA product code | HTR |
| Device type | Rasp |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2015-10-05 |
| Record revised | 2021-06-03 (version 5) |
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 | Height 5 to 12 mm; width 16 to 18 mm; length 13 to 14 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T066-0622 | Width 18 mm | In distribution |
| T066-0621 | Length 14 mm | In distribution |
| T066-0624 | Height 9 mm | In distribution |
| T066-0627 | Length 14 mm | In distribution |
| T066-0135 | Length 13 mm | In distribution |
| T066-0134 | Length 13 mm | In distribution |
| T066-0122 | Width 16 mm | In distribution |
| T066-0632 | Height 7 mm | In distribution |
| T066-0693 | Width 16 mm | In distribution |
| T066-0635 | Height 10 mm | In distribution |
| T066-0121 | Width 16 mm | In distribution |
| T066-0626 | Length 14 mm | In distribution |
| T066-0691 | Width 16 mm | In distribution |
| T066-0696 | Length 13 mm | In distribution |
| T066-0690 | Width 16 mm | In distribution |
| T066-0630 | Length 14 mm | In distribution |
| C066-0092 | Height 7 mm | In distribution |
| T066-0123 | Length 13 mm | In distribution |
| T066-0133 | Length 13 mm | In distribution |
| C066-0096 | Height 11 mm | In distribution |
| T066-0636 | Height 11 mm | In distribution |
| T066-0130 | Width 16 mm | In distribution |
| T066-0136 | Height 11 mm | In distribution |
| T066-0637 | Height 12 mm | In distribution |
| T066-0124 | Width 16 mm | In distribution |
| T066-0692 | Height 7 mm | In distribution |
| T066-0697 | Length 13 mm | In distribution |
| T066-0120 | Length 13 mm | In distribution |
| C066-0094 | Height 9 mm | In distribution |
| T066-0126 | Height 11 mm | In distribution |
| T066-0132 | Height 7 mm | In distribution |
| T066-0694 | Width 16 mm | In distribution |
| T066-0137 | Length 13 mm | In distribution |
| C066-0090 | Height 5 mm | In distribution |
| T066-0620 | Length 14 mm | In distribution |
| T066-0127 | Length 13 mm | In distribution |
| T066-0131 | Length 13 mm | In distribution |
| T066-0631 | Length 14 mm | In distribution |
| T066-0695 | Height 10 mm | In distribution |
| T066-0625 | Length 14 mm | In distribution |
| T066-0125 | Length 13 mm | In distribution |
| T066-0634 | Width 18 mm | In distribution |
| T066-0623 | Length 14 mm | In distribution |
| T066-0633 | Length 14 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.