LCS
LCS Distal Femoral Resection Block 2 Degrees V/V
11manufacturers in China registered for this device type
11catalogue 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 | 2015-03-24 |
| Record revised | 2023-05-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9505-01-072 | In distribution | |
| 2277-10-000 | In distribution | |
| 9505-01-075 | In distribution | |
| 9505-01-076 | In distribution | |
| 9505-01-073 | In distribution | |
| 2287-46-000 | In distribution | |
| 2287-41-000 | In distribution | |
| 2287-44-000 | In distribution | |
| 2287-43-000 | In distribution | |
| 9505-01-074 | In distribution | |
| 2287-42-000 | 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
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.