Punch, Surgical
Troch Nail Anti-Rotation Bar
9manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Guangdong (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 |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
Record
| Listed by | Ortho Development Corp., United States |
|---|---|
| FDA product code | LRY |
| Device type | Punch, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-02-28 |
| Record revised | 2023-08-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 880-0300 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 693 |
| Ambler Surgical | Ambler Surgical, LLC | 317 |
| Orthomed | Ortho-MED, Inc. | 228 |
| Aesculap | Aesculap AG | 187 |
| Lazic | Peter Lazic Gmbh | 148 |
| Noir | Aesculap AG | 66 |
| MaxMoreSpine | Hoogland Spine Products GmbH | 44 |
| Kerrison | Elliquence LLC | 36 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 33 |
| Punch, Surgical | Doppkon Gmbh & Co. KG | 29 |
| Scharf | Scharf Tools Ihracat Ithalat Limited Sirketi | 29 |
| Henry Schein | Henry Schein, Inc. | 27 |
Showing 12 of 216. All products under Punch, Surgical
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.