Calix Spinal Implant System
32mm x 10mm x 11mm PLIF BOX BROACH
12manufacturers in China registered for this device type
40catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (2), Guangdong (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Changzhou Master Precision Tool Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Changzhou Xietong Industries Co., Ltd. | Changzhou | Jiangsu | Exporter | 11 |
| Changzhou Centrau Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
Record
| Listed by | Xtant Medical Holdings, Inc., United States |
|---|---|
| FDA product code | HTQ |
| Device type | Broach |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2015-11-13 |
| 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 | Length 22 to 36 mm; width 10 to 24 mm; height 6 to 20 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X034-1485 | Length 32 mm | In distribution |
| X034-1134 | Length 22 mm | In distribution |
| X034-1150 | Height 6 mm | In distribution |
| X034-1151 | Length 26 mm | In distribution |
| X034-1140 | Length 22 mm | In distribution |
| X034-1133 | Length 22 mm | In distribution |
| X034-1135 | Height 11 mm | In distribution |
| X034-1136 | Height 12 mm | In distribution |
| X034-1131 | Width 10 mm | In distribution |
| X034-1153 | Length 26 mm | In distribution |
| X034-1138 | Length 22 mm | In distribution |
| X034-1490 | Width 10 mm | In distribution |
| X034-1139 | Width 10 mm | In distribution |
| X034-1480 | Height 6 mm | In distribution |
| X034-1158 | Height 14 mm | In distribution |
| X034-1483 | Width 10 mm | In distribution |
| X034-1482 | Width 10 mm | In distribution |
| X034-1155 | Length 26 mm | In distribution |
| X034-1233 | Height 14 mm | In distribution |
| X034-1160 | Height 16 mm | In distribution |
| X034-1231 | Width 24 mm | In distribution |
| X034-1156 | Height 12 mm | In distribution |
| X034-1159 | Height 15 mm | In distribution |
| X034-1481 | Width 10 mm | In distribution |
| X034-1484 | Width 10 mm | In distribution |
| X034-1487 | Length 32 mm | In distribution |
| X034-1154 | Length 26 mm | In distribution |
| X034-1486 | Height 12 mm | In distribution |
| X034-1489 | Width 10 mm | In distribution |
| X034-1157 | Height 13 mm | In distribution |
| X034-1232 | Width 24 mm | In distribution |
| X034-1230 | Height 8 mm | In distribution |
| X034-1152 | Height 8 mm | In distribution |
| X034-1130 | Length 22 mm | In distribution |
| X034-1234 | Width 24 mm | In distribution |
| X034-1236 | Height 20 mm | In distribution |
| X034-1488 | Height 14 mm | In distribution |
| X034-1132 | Length 22 mm | In distribution |
| X034-1235 | Height 18 mm | In distribution |
| X034-1137 | Height 13 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DJO Surgical | Encore Medical, L.P. | 132 |
| Intervertebral Disc Preparation Instruments | Alphatec Spine, Inc. | 119 |
| DJO Surgical | DJO, LLC | 89 |
| iNSitu™ Hip System | Nextstep Arthropedix | 84 |
| OrthoMedFlex | Orthomedflex LLC | 63 |
| Anthology | Smith & Nephew, Inc. | 56 |
| LinkBio Instrument | Link BIO Corp | 53 |
| Profemur® | Microport Orthopedics Inc. | 47 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 39 |
| Polar | Smith & Nephew, Inc. | 36 |
| Integra® | Ascension Orthopedics, Inc. | 36 |
| Plif | Depuy Spine, Inc. | 35 |
Showing 12 of 216. All products under Broach
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.