Ennovate
ENNOVATE Counter Torque, (180 mm), silicone handle, steel, non-sterile, reusable, to be used with: SZ277R
53manufacturers in China registered for this device type
50catalogue numbers in this listing
5recalls on this code
Who Else Makes It
Concentrated in Jiangsu (24), Guangdong (7), Zhejiang (6). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
Showing 12 of 53. All 53 manufacturers in China registered for Orthopedic Manual Surgical Instrument
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-08-10 |
| Record revised | 2025-11-20 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2024-10-09 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SZ393R | Withdrawn | ||
| SZ249R | Withdrawn | ||
| SZ398P | Withdrawn | ||
| SZ225R | Withdrawn | ||
| SZ351R | Withdrawn | ||
| SZ365R | Length : 225.000 MM | Withdrawn | |
| SZ273R | Length : 255.000 MM | Withdrawn | |
| SZ297R | Withdrawn | ||
| SZ373T | Withdrawn | ||
| SZ395R | Withdrawn | ||
| SZ392R | Withdrawn | ||
| SZ378R | Withdrawn | ||
| SZ222R | Withdrawn | ||
| SZ283R | Withdrawn | ||
| SZ388R | 2 | Withdrawn | |
| SZ282R | Withdrawn | ||
| SZ385R | Withdrawn | ||
| SZ390R | Withdrawn | ||
| SZ394T | Withdrawn | ||
| SZ387R | Length : 180.000 MM | Withdrawn | |
| SZ290R | Withdrawn | ||
| SZ234R | Withdrawn | ||
| SZ406R | Withdrawn | ||
| SZ224R | Withdrawn | ||
| SZ267SU | Withdrawn | ||
| SZ275R | Withdrawn | ||
| SZ372T | Withdrawn | ||
| SZ241R | Withdrawn | ||
| SZ399R | Withdrawn | ||
| SZ380R | Withdrawn | ||
| SZ370 | Withdrawn | ||
| SZ233R | Withdrawn | ||
| SZ384R | Withdrawn | ||
| SZ407R | Withdrawn | ||
| SZ277R | Withdrawn | ||
| SZ412R | Withdrawn | ||
| SZ369S | Withdrawn | ||
| SZ366R | Withdrawn | ||
| SZ252R | Withdrawn | ||
| SZ396R | Withdrawn | ||
| SZ276R | Length : 180.000 MM | Withdrawn | |
| SZ248R | Withdrawn | ||
| SZ265R | Length : 255.000 MM | Withdrawn | |
| SZ405R | Withdrawn | ||
| SZ374T | Withdrawn | ||
| SZ253R | Withdrawn | ||
| SZ389R | Length : 170.000 MM | Withdrawn | |
| SZ295R | Withdrawn | ||
| SZ411R | Withdrawn | ||
| SZ375T | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Razek Equipamentos | Razek Equipamentos Ltda | 11,578 |
| Orthopedic Manual Surgical Instrument | Globus Medical, Inc. | 4,784 |
| Instrument | Howmedica Osteonics Corp | 4,539 |
| Orthopedic Manual Surgical Instrument | Ortho Development Corp. | 4,076 |
| Knee Instruments | Medacta International SA | 3,944 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 3,420 |
| Arthrex® | Arthrex, Inc. | 3,106 |
| Spine Instruments | Medacta International SA | 2,892 |
| Orthopedic Manual Surgical Instrument | Medtronic Sofamor Danek, Inc. | 2,766 |
| Hip Instruments | Medacta International SA | 1,904 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 1,756 |
| ReLine | Nuvasive, Inc. | 1,208 |
Showing 12 of 9,501. All products under Orthopedic Manual Surgical Instrument
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Aesculap AG | UDI-DI | 2020-11-18 | Class II | Component design/selection | Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system. Redesign of removal key. | 17 | 2024-12-23 |
| Aesculap AG | UDI-DI | 2020-07-13 | Class II | Component design/selection | Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system. | 16 | 2024-04-26 |
Recalls
3 of these are 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 |
|---|---|---|---|---|---|
| 2019-11-12 | Class II | Device Design | Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring. | 67 | |
| 2013-09-20 | Class II | Device Design | The trial insertion instrument may disassemble during use due to a potentially weak weld on then trial inserter shaft block area located near the thumb wheel. | 30 | 2014-12-16 |
| 2012-05-09 | Class II | Process change control | The manufacturer informed the recalling firm of a potential laser marking error in size identification on two Columbus 4-IN-1 Femoral Cutting Guide Instruments. The guides are correctly dimensioned, but the laser markings have been incorre | 2 | 2014-01-15 |
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.