General Instrument
BATTALION, LLIF PRIMARY DISTRACTOR, 1/4" SQ. M/L ANGLED LORDOTIC, 18 mm X 10 mm
5manufacturers in China registered for this device type
85catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
Record
| Listed by | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | HTE |
| Device type | Elevator |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-10-13 |
| Record revised | 2023-03-30 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CI-10685-06 | In distribution | |
| CI-10801-05 | In distribution | |
| CI-11090-03 | In distribution | |
| CI-10792-150-1200 | In distribution | |
| CI-10685-11 | In distribution | |
| CI-11202-10 | In distribution | |
| CI-10685-14 | In distribution | |
| CI-10768-1806 | In distribution | |
| CI-10835-35-18 | In distribution | |
| CI-10767-1810 | In distribution | |
| CI-10685-08 | In distribution | |
| CI-10802-100-1800 | In distribution | |
| CI-11161-20 | In distribution | |
| CI-11234-130 | In distribution | |
| CI-11114-04342410 | In distribution | |
| CI-11202-14 | In distribution | |
| CI-10815 | In distribution | |
| CI-10828-20 | In distribution | |
| CI-10869 | In distribution | |
| CI-10801-07 | In distribution | |
| CI-10792-110-1200 | In distribution | |
| CI-10740-400-18 | In distribution | |
| CI-10725-100-1804 | In distribution | |
| CI-11143 | In distribution | |
| CI-11234-140 | In distribution | |
| CI-10361 | In distribution | |
| CI-10740-700-18 | In distribution | |
| CI-10725-100-1808 | In distribution | |
| CI-10767-1814 | In distribution | |
| CI-10801-11 | In distribution | |
| CI-11039-14 | In distribution | |
| CI-10740-300-18 | In distribution | |
| CI-11202-12 | In distribution | |
| CI-11090-01 | In distribution | |
| CI-10742 | In distribution | |
| CI-11125-08 | In distribution | |
| CI-10854 | In distribution | |
| CI-10740-300-28 | In distribution | |
| CI-10960 | In distribution | |
| CI-11138 | In distribution | |
| CI-10767-2208 | In distribution | |
| CI-11202-16 | In distribution | |
| CI-10792-130-1200 | In distribution | |
| CI-10685-16 | In distribution | |
| CI-10825 | In distribution | |
| CI-11202-06 | In distribution | |
| CI-10740-100-18 | In distribution | |
| CI-10801-09 | In distribution | |
| CI-10767-2212 | In distribution | |
| CI-10740-600-18 | In distribution | |
| CI-10725-100-1806 | In distribution | |
| CI-11202-08 | In distribution | |
| CI-10835-35-12 | In distribution | |
| CI-10767-1812 | In distribution | |
| CI-10685-09 | In distribution | |
| CI-10685-10 | In distribution | |
| CI-11103-04382810 | In distribution | |
| CI-10740-100-28 | In distribution | |
| CI-10685-15 | In distribution | |
| CI-10768-1804 | In distribution | |
| CI-10767-1808 | In distribution | |
| CI-11114-04342410-20 | In distribution | |
| CI-11125-10 | In distribution | |
| CI-10685-13 | In distribution | |
| CI-11065-043424 | In distribution | |
| CI-10685-05 | In distribution | |
| CI-10767-2210 | In distribution | |
| CI-11103-04342410 | In distribution | |
| CI-10792-160-1200 | In distribution | |
| CI-10908 | In distribution | |
| CI-10685-12 | In distribution | |
| CI-10828-10 | In distribution | |
| CI-11161-30 | In distribution | |
| CI-10767-2214 | In distribution | |
| CI-10916 | In distribution | |
| CI-11065-043828 | In distribution | |
| CI-10801-13 | In distribution | |
| CI-10850-110-2200 | In distribution | |
| CI-10801-15 | In distribution | |
| CI-10740-500-18 | In distribution | |
| CI-11125-12 | In distribution | |
| CI-11234-40 | In distribution | |
| CI-10685-07 | In distribution | |
| CI-11165 | In distribution | |
| CI-10740-200-18 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Life Instruments | Life Instrument Corp. | 383 |
| General Instruments | Alphatec Spine, Inc. | 326 |
| Timberline Lateral Fusion System | Highridge Medical, LLC | 209 |
| Battalion | Alphatec Spine, Inc. | 152 |
| IdentiTi | Alphatec Spine, Inc. | 110 |
| Intervertebral Disc Preparation Instruments | Alphatec Spine, Inc. | 103 |
| Orthomed | Ortho-MED, Inc. | 100 |
| Tecomet | Tecomet, Inc. | 88 |
| Innomed, Inc. | Innomed, Inc. | 85 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 71 |
| Elmed | Elmed, Inc. | 67 |
| Elevator | Depuy Spine, Inc. | 56 |
Showing 12 of 246. All products under Elevator
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.