DJO Surgical
DJO Empowr Kneetm Cemented Stemmable Tibial Punch, Medium
9manufacturers in China registered for this device type
11catalogue numbers in this listing
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 | Encore Medical, L.P., United States |
|---|---|
| FDA product code | LRY |
| Device type | Punch, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K171991 |
| Record published | 2017-10-26 |
| Record revised | 2023-05-03 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 801-05-203 | In distribution | |
| 801-05-049 | In distribution | |
| 801-03-049 | In distribution | |
| 801-05-020 | In distribution | |
| 801-05-051 | In distribution | |
| 801-03-026 | In distribution | |
| 801-05-202 | In distribution | |
| 801-05-040 | In distribution | |
| 801-05-050 | In distribution | |
| 801-05-204 | In distribution | |
| 801-05-205 | 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
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Encore Medical, L.P. | UDI-DI | 2023-09-29 | Class II | Process change control | Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery. | 406 |
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.