Novel
Bullet-nosed Disc Shavers - 15 mm
11manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Zhejiang (3), Shandong (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| 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 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Shanghai Lange Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 16 |
Record
| Listed by | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | HTZ |
| Device type | Instrument, Cutting, Orthopedic |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-09-19 |
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-10201-14 | In distribution | |
| CI-10201-12 | In distribution | |
| CI-10201-13 | In distribution | |
| CI-10201-07 | In distribution | |
| CI-10201-15 | In distribution | |
| CI-10201-11 | In distribution | |
| CI-10201-08 | In distribution | |
| CI-10201-10 | In distribution | |
| CI-10201-09 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| General Instruments | Alphatec Spine, Inc. | 138 |
| Attune | Depuy Orthopaedics, Inc. | 108 |
| General Instrument | Alphatec Spine, Inc. | 101 |
| Battalion | Alphatec Spine, Inc. | 86 |
| Attune | Depuy (Ireland) | 79 |
| Intervertebral Disc Preparation Instruments | Alphatec Spine, Inc. | 79 |
| Sklar® | Sklar Corporation | 56 |
| Newclip Instruments | Newclip Technics SAS | 54 |
| Sigma | Depuy Orthopaedics, Inc. | 40 |
| IdentiTi | Alphatec Spine, Inc. | 38 |
| Sigma | Depuy (Ireland) | 29 |
| Specialist | Depuy (Ireland) | 28 |
Showing 12 of 208. All products under Instrument, Cutting, Orthopedic
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.