General Instrument
LLIF Broach, 8 mm x 18 mm, Flat Top Surface
12manufacturers in China registered for this device type
23catalogue 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 | Alphatec Spine, 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, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-10-13 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CI-10963-1806 | In distribution | |
| CI-10823-1812 | In distribution | |
| CI-10963-1804 | In distribution | |
| CI-10857-100-1208 | In distribution | |
| CI-10823-2208 | In distribution | |
| CI-11135-06 | In distribution | |
| CI-10823-1810 | In distribution | |
| CI-10823-1806 | In distribution | |
| CI-10823-2210 | In distribution | |
| CI-11073-2206 | In distribution | |
| CI-10857-100-1204 | In distribution | |
| CI-11073-2208 | In distribution | |
| CI-11055-04 | In distribution | |
| CI-10823-2206 | In distribution | |
| CI-10857-100-1210 | In distribution | |
| CI-10823-1808 | In distribution | |
| CI-10823-2212 | In distribution | |
| CI-11055-06 | In distribution | |
| CI-11073-1808 | In distribution | |
| CI-10857-100-1206 | In distribution | |
| CI-11212-1404 | In distribution | |
| CI-11135-08 | In distribution | |
| CI-11135-04 | 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 |
| Calix Spinal Implant System | Xtant Medical Holdings, Inc. | 40 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 39 |
| Polar | Smith & Nephew, Inc. | 36 |
| Integra® | Ascension Orthopedics, Inc. | 36 |
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.