S-ROM
S-ROM MI Triangle Miller Cutter Size 20
11manufacturers in China registered for this device type
13catalogue numbers in this listing
1recall
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 | Depuy Orthopaedics, Inc., United States |
|---|---|
| FDA product code | HTZ |
| Device type | Instrument, Cutting, Orthopedic |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-09-24 |
| Record revised | 2026-05-01 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
| Distribution end date | 2026-04-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2576-08-020 | In distribution | |
| 2576-08-014 | In distribution | |
| 54-0020 | In distribution | |
| 54-0018 | In distribution | |
| 2576-08-022 | In distribution | |
| 2576-08-016 | In distribution | |
| 2576-08-012 | In distribution | |
| 2576-08-018 | In distribution | |
| 54-0022 | Withdrawn | |
| 54-0014 | Withdrawn | |
| 54-0016 | Withdrawn | |
| 54-0012 | Withdrawn | |
| 54-0024 | Withdrawn |
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
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-01-03 | Class II | Process control | The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery. | 140 total units | 2021-08-12 |
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.