Intervertebral Disc Preparation Instruments
LIF, Broach, CC Offset, 14MM X 08MM
12manufacturers in China registered for this device type
119catalogue 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 | 2021-12-18 |
| Record revised | 2024-02-22 (version 2) |
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 4 to 16 mm; width 14 to 18 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 256-15-100-1812 | Height 12 mm | In distribution |
| 256-15-300-1411 | Height 11 mm | In distribution |
| 256-15-000-1806 | Height 6 mm | In distribution |
| 256-15-000-1604 | Height 4 mm | In distribution |
| 256-15-100-1408 | Width 14 mm | In distribution |
| 256-15-000-1410 | Height 10 mm | In distribution |
| 256-15-100-1415 | Width 14 mm | In distribution |
| 256-15-000-1413 | Height 13 mm | In distribution |
| 256-15-000-1407 | Width 14 mm | In distribution |
| 256-15-000-1812 | Height 12 mm | In distribution |
| 256-15-100-1409 | Width 14 mm | In distribution |
| 256-15-000-1608 | Width 16 mm | In distribution |
| 256-15-300-1816 | Height 16 mm | In distribution |
| 256-15-300-1806 | Width 18 mm | In distribution |
| 256-15-100-1608 | Width 16 mm | In distribution |
| 256-15-300-1810 | Height 10 mm | In distribution |
| 256-15-100-1606 | Height 6 mm | In distribution |
| 256-15-100-1413 | Height 13 mm | In distribution |
| 256-15-300-1409 | Width 14 mm | In distribution |
| 256-15-000-1405 | Height 5 mm | In distribution |
| 256-15-000-1414 | Height 14 mm | In distribution |
| 256-15-000-1615 | Height 15 mm | In distribution |
| 256-15-300-1605 | Width 16 mm | In distribution |
| 256-15-300-1805 | Width 18 mm | In distribution |
| 256-15-100-1405 | Width 14 mm | In distribution |
| 256-15-100-1613 | Height 13 mm | In distribution |
| 256-15-100-1813 | Width 18 mm | In distribution |
| 256-15-100-1614 | Height 14 mm | In distribution |
| 256-15-300-1812 | Height 12 mm | In distribution |
| 256-15-000-1613 | Width 16 mm | In distribution |
| 256-15-300-1811 | Width 18 mm | In distribution |
| 256-15-300-1416 | Width 14 mm | In distribution |
| 256-15-000-1416 | Width 14 mm | In distribution |
| 256-15-300-1809 | Width 18 mm | In distribution |
| 256-15-300-1405 | Height 5 mm | In distribution |
| 256-15-100-1610 | Width 16 mm | In distribution |
| 256-15-000-2210 | In distribution | |
| 256-15-300-1814 | Height 14 mm | In distribution |
| 256-15-300-1813 | Width 18 mm | In distribution |
| 256-15-100-1411 | Height 11 mm | In distribution |
| 256-15-000-1811 | Height 11 mm | In distribution |
| 256-15-000-2208 | In distribution | |
| 256-15-000-1805 | Height 5 mm | In distribution |
| 256-15-100-1407 | Width 14 mm | In distribution |
| 256-15-300-1808 | Width 18 mm | In distribution |
| 256-15-100-1406 | Height 6 mm | In distribution |
| 256-15-100-1809 | Height 9 mm | In distribution |
| 256-15-300-1807 | Width 18 mm | In distribution |
| 256-15-300-1404 | Width 14 mm | In distribution |
| 256-15-000-1606 | Height 6 mm | In distribution |
| 256-15-000-1611 | Height 11 mm | In distribution |
| 256-15-000-1607 | Width 16 mm | In distribution |
| 256-15-000-1415 | Height 15 mm | In distribution |
| 256-15-100-1607 | Height 7 mm | In distribution |
| 256-15-300-1804 | Height 4 mm | In distribution |
| 256-15-000-1605 | Height 5 mm | In distribution |
| 256-15-300-1815 | Width 18 mm | In distribution |
| 256-15-100-1412 | Width 14 mm | In distribution |
| 256-15-100-1616 | Height 16 mm | In distribution |
| 256-15-000-1411 | Height 11 mm | In distribution |
| 256-15-100-1612 | Width 16 mm | In distribution |
| 256-15-300-1616 | Width 16 mm | In distribution |
| 256-15-300-1412 | Width 14 mm | In distribution |
| 256-15-000-1412 | Height 12 mm | In distribution |
| 256-15-300-1410 | Width 14 mm | In distribution |
| 256-15-000-1404 | Height 4 mm | In distribution |
| 256-15-000-1814 | Width 18 mm | In distribution |
| 256-15-100-1808 | Width 18 mm | In distribution |
| 256-15-100-1404 | Width 14 mm | In distribution |
| 256-15-300-1607 | Height 7 mm | In distribution |
| 256-15-000-1614 | Height 14 mm | In distribution |
| 256-15-300-1610 | Height 10 mm | In distribution |
| 256-15-100-1815 | Width 18 mm | In distribution |
| 256-15-000-1616 | Width 16 mm | In distribution |
| 256-15-100-1811 | Height 11 mm | In distribution |
| 256-15-100-1416 | Height 16 mm | In distribution |
| 256-15-000-1804 | Width 18 mm | In distribution |
| 256-15-000-1609 | Height 9 mm | In distribution |
| 256-15-000-1810 | Height 10 mm | In distribution |
| 256-15-000-1813 | Height 13 mm | In distribution |
| 256-15-300-1407 | Height 7 mm | In distribution |
| 256-15-000-1815 | Height 15 mm | In distribution |
| 256-15-000-1610 | Width 16 mm | In distribution |
| 256-15-000-1816 | Height 16 mm | In distribution |
| 256-15-300-1606 | Height 6 mm | In distribution |
| 256-15-300-1414 | Width 14 mm | In distribution |
| 256-15-100-1410 | Width 14 mm | In distribution |
| 256-15-300-1611 | Width 16 mm | In distribution |
| 256-15-000-1809 | Width 18 mm | In distribution |
| 256-15-300-1612 | Width 16 mm | In distribution |
| 256-15-300-1614 | Height 14 mm | In distribution |
| 256-15-300-1408 | Width 14 mm | In distribution |
| 256-15-000-1612 | Height 12 mm | In distribution |
| 256-15-300-1615 | Height 15 mm | In distribution |
| 256-15-100-1609 | Width 16 mm | In distribution |
| 256-15-000-1807 | Width 18 mm | In distribution |
| 256-15-100-1806 | Height 6 mm | In distribution |
| 256-15-100-1807 | Height 7 mm | In distribution |
| 256-15-100-1414 | Height 14 mm | In distribution |
| 256-15-100-1615 | Width 16 mm | In distribution |
| 256-15-300-1609 | Width 16 mm | In distribution |
| 256-15-100-1611 | Height 11 mm | In distribution |
| 256-15-100-1605 | Width 16 mm | In distribution |
| 256-15-000-1406 | Height 6 mm | In distribution |
| 256-15-300-1413 | Width 14 mm | In distribution |
| 256-15-000-1409 | Width 14 mm | In distribution |
| 256-15-100-1604 | Height 4 mm | In distribution |
| 256-15-300-1608 | Height 8 mm | In distribution |
| 256-15-100-1814 | Width 18 mm | In distribution |
| 256-15-300-1406 | Height 6 mm | In distribution |
| 256-15-100-1805 | Width 18 mm | In distribution |
| 256-15-100-1816 | Width 18 mm | In distribution |
| 256-15-100-1810 | Height 10 mm | In distribution |
| 256-15-000-1408 | Width 14 mm | In distribution |
| 256-15-100-1804 | Height 4 mm | In distribution |
| 256-15-300-1415 | Height 15 mm | In distribution |
| 256-15-300-1604 | Height 4 mm | In distribution |
| 256-15-000-1808 | Height 8 mm | In distribution |
| 256-15-300-1613 | Height 13 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DJO Surgical | Encore Medical, L.P. | 132 |
| 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 |
| 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.