Calix Spinal Implant System
10 MM, Specialty Plif Lollipop Rasp W/ TEE Handle Assembly.
12manufacturers in China registered for this device type
143catalogue 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 | 2018-02-26 |
| 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, expiry date |
| Sizes | Height 4 to 20 mm; width 10 to 24 mm; length 22 to 36 mm; depth 13 to 15 mm; angle 8 to 12 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X003-0700 | Depth 15 mm | In distribution |
| X003-0702 | Depth 15 mm | In distribution |
| X034-0758 | Width 10 mm | In distribution |
| X034-0360 | Length 28 mm | In distribution |
| X034-1332 | Height 8 mm | In distribution |
| X034-1203 | Width 24 mm | In distribution |
| X034-1217 | Length 36 mm | In distribution |
| X034-1000 | Length 22 mm | In distribution |
| C034-0016 | Height 9 mm | In distribution |
| X034-0995 | Width 10 mm | In distribution |
| X034-1202 | Width 24 mm | In distribution |
| X003-0280 | 16mm width x 5mm height | In distribution |
| X034-2885 | Width 10 mm | In distribution |
| X034-1200 | Height 8 mm | In distribution |
| X034-1074 | Height 10 mm | In distribution |
| X034-1339 | Length 32 mm | In distribution |
| X003-0060 | Height 10 mm | In distribution |
| X034-0992 | Width 10 mm | In distribution |
| X034-0756 | Height 12 mm | In distribution |
| C034-0251 | In distribution | |
| X034-1221 | Angle 12 ° | In distribution |
| X003-0706 | Depth 15 mm | In distribution |
| X034-0361 | Length 28 mm | In distribution |
| X034-1333 | Height 9 mm | In distribution |
| X034-1218 | Width 24 mm | In distribution |
| X034-0363 | Width 10 mm | In distribution |
| C003-0028 | In distribution | |
| C003-0032 | In distribution | |
| X034-2884 | Width 10 mm | In distribution |
| X034-2728 | Length 28 mm | In distribution |
| C003-0030 | In distribution | |
| X034-1219 | Length 36 mm | In distribution |
| X034-0368 | Height 14 mm | In distribution |
| X003-0704 | Depth 15 mm | In distribution |
| X034-0990 | Width 10 mm | In distribution |
| X034-2801 | Height 7 mm | In distribution |
| X003-0282 | 16mm width x 7mm height | In distribution |
| X003-0057 | Height 7 mm | In distribution |
| C003-0027 | In distribution | |
| X034-2882 | Height 8 mm | In distribution |
| X034-2724 | Height 10 mm | In distribution |
| X034-1206 | Length 36 mm | In distribution |
| X034-2886 | Width 10 mm | In distribution |
| X003-0283 | Depth 13 mm | In distribution |
| X003-0062 | Height 12 mm | In distribution |
| C034-0015 | Height 8 mm | In distribution |
| X034-0993 | Length 22 mm | In distribution |
| X034-0759 | Width 10 mm | In distribution |
| X034-1331 | Height 7 mm | In distribution |
| X034-2880 | Length 26 mm | In distribution |
| X034-0754 | Length 32 mm | In distribution |
| X034-2805 | Height 11 mm | In distribution |
| X034-0750 | Height 6 mm | In distribution |
| X034-0364 | Length 28 mm | In distribution |
| X034-1076 | Width 10 mm | In distribution |
| X034-1077 | Width 10 mm | In distribution |
| X034-2721 | Length 28 mm | In distribution |
| X034-2804 | Length 22 mm | In distribution |
| X034-1073 | Length 26 mm | In distribution |
| X034-2808 | Height 14 mm | In distribution |
| X034-1337 | Length 32 mm | In distribution |
| X034-0369 | Height 15 mm | In distribution |
| X034-2887 | Height 13 mm | In distribution |
| C003-0033 | In distribution | |
| X034-2890 | Height 16 mm | In distribution |
| X034-0760 | Length 32 mm | In distribution |
| X034-1204 | Height 16 mm | In distribution |
| X034-0991 | Height 7 mm | In distribution |
| X034-0365 | Height 11 mm | In distribution |
| X034-0751 | Height 7 mm | In distribution |
| X034-0370 | Height 16 mm | In distribution |
| X034-0362 | Length 28 mm | In distribution |
| X003-0056 | Height 6 mm | In distribution |
| X003-0285 | 16mm width x 10mm height | In distribution |
| X003-0701 | 18mm width x 6mm height | In distribution |
| X003-0055 | Height 5 mm | In distribution |
| X034-1340 | Length 32 mm | In distribution |
| X034-1335 | Height 11 mm | In distribution |
| X034-2729 | Width 10 mm | In distribution |
| C034-0218 | Height 5 mm | In distribution |
| X034-2726 | Width 10 mm | In distribution |
| X034-1216 | Height 10 mm | In distribution |
| X034-2730 | Height 16 mm | In distribution |
| X034-2800 | Length 22 mm | In distribution |
| X034-1078 | Length 26 mm | In distribution |
| X034-0367 | Width 10 mm | In distribution |
| X034-1079 | Length 26 mm | In distribution |
| X003-0059 | Height 9 mm | In distribution |
| X034-2802 | Width 10 mm | In distribution |
| X003-0705 | Depth 15 mm | In distribution |
| X034-2803 | Height 9 mm | In distribution |
| X003-0058 | Height 8 mm | In distribution |
| X034-1070 | Length 26 mm | In distribution |
| X034-0999 | Length 22 mm | In distribution |
| X003-0703 | Depth 15 mm | In distribution |
| X034-2806 | Width 10 mm | In distribution |
| C034-0217 | Height 4 mm | In distribution |
| X034-1330 | Width 10 mm | In distribution |
| X003-0707 | Depth 15 mm | In distribution |
| X034-2889 | Width 10 mm | In distribution |
| X003-0281 | Depth 13 mm | In distribution |
| X034-1201 | Width 24 mm | In distribution |
| X034-2720 | Width 10 mm | In distribution |
| X034-2810 | Width 10 mm | In distribution |
| X034-2881 | Length 26 mm | In distribution |
| X034-2722 | Length 28 mm | In distribution |
| X034-1334 | Height 10 mm | In distribution |
| X034-1080 | Height 16 mm | In distribution |
| X034-1205 | Width 24 mm | In distribution |
| X034-0996 | Height 12 mm | In distribution |
| X034-1336 | Length 32 mm | In distribution |
| C003-0026 | In distribution | |
| X034-1075 | Height 11 mm | In distribution |
| X034-0757 | Height 13 mm | In distribution |
| X034-2888 | Width 10 mm | In distribution |
| X034-2727 | Width 10 mm | In distribution |
| C034-0253 | In distribution | |
| X034-1071 | Height 7 mm | In distribution |
| C003-0029 | In distribution | |
| X003-0286 | Depth 13 mm | In distribution |
| C003-0031 | In distribution | |
| X034-0752 | Length 32 mm | In distribution |
| X034-0998 | Width 10 mm | In distribution |
| X034-0755 | Height 11 mm | In distribution |
| X003-0287 | Depth 13 mm | In distribution |
| X003-0284 | 16mm width x 9mm height | In distribution |
| X003-0061 | Height 11 mm | In distribution |
| X034-2723 | Height 9 mm | In distribution |
| X034-1220 | Length 36 mm | In distribution |
| X034-1072 | Length 26 mm | In distribution |
| X034-0994 | Width 10 mm | In distribution |
| X034-0753 | Length 32 mm | In distribution |
| X034-2809 | Length 22 mm | In distribution |
| C034-0013 | Height 6 mm | In distribution |
| X034-1215 | Height 8 mm | In distribution |
| X034-0366 | Height 12 mm | In distribution |
| X034-1338 | Length 32 mm | In distribution |
| X034-2883 | Height 9 mm | In distribution |
| X034-2725 | Length 28 mm | In distribution |
| X034-0997 | Height 13 mm | In distribution |
| C034-0017 | Height 10 mm | In distribution |
| C034-0014 | Height 7 mm | In distribution |
| X034-2807 | Height 13 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 |
| 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 |
| Rasp | Zimmer, Inc. | 77 |
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.