TSI
Quick Start Distraction Screw, 14 MM, Sterile, 5/BOX
53manufacturers in China registered for this device type
71catalogue numbers in this listing
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 | Tedan Surgical Innovations, L.L.C. |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2017-08-08 |
| Record revised | 2026-03-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Inner box of 5 |
| Sizes | Length 12 to 16 mm |
| Distribution end date | 2023-09-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AL-0105 | In distribution | |
| UL-0108 | In distribution | |
| CS-0126 | In distribution | |
| CS-0128 | In distribution | |
| LS-0103 | In distribution | |
| CS-0131 | In distribution | |
| CS-0127 | In distribution | |
| LS-0390 | In distribution | |
| CS-0122 | In distribution | |
| CS-0123 | In distribution | |
| DS-0222 | In distribution | |
| HS-0155 | In distribution | |
| CS-1305 | In distribution | |
| UL-0111 | In distribution | |
| DS-0232 | In distribution | |
| CS-0134 | In distribution | |
| DS-0234 | In distribution | |
| CS-0137 | In distribution | |
| CS-0133 | In distribution | |
| CS-0130 | In distribution | |
| DS-0024 | Length 14 mm | In distribution |
| DS-0022 | Length 12 mm | In distribution |
| DS-0224 | In distribution | |
| CS-0135 | In distribution | |
| VPR0205 | In distribution | |
| LS-0201 | In distribution | |
| LS-0105 | In distribution | |
| CS-0129 | In distribution | |
| CS-0117 | In distribution | |
| CS-0125 | In distribution | |
| CS-0115 | In distribution | |
| DS-0214 | In distribution | |
| DS-0012 | Length 12 mm | In distribution |
| DS-0016 | Length 16 mm | In distribution |
| LS-0102 | In distribution | |
| DS-0026 | Length 16 mm | In distribution |
| CS-0110 | In distribution | |
| DS-0226 | In distribution | |
| CS-0139 | In distribution | |
| CS-0119 | In distribution | |
| DS-0216 | In distribution | |
| CS-0124 | In distribution | |
| CS-0136 | In distribution | |
| DS-0014 | Length 14 mm | In distribution |
| AL-0102 | In distribution | |
| CS-0112 | In distribution | |
| CS-0109 | In distribution | |
| CS-0121 | In distribution | |
| UL-0117 | In distribution | |
| VPR1305 | In distribution | |
| VPR0203 | In distribution | |
| CS-0116 | In distribution | |
| CS-1710 | In distribution | |
| CS-0325 | In distribution | |
| CS-0149 | In distribution | |
| CS-0105 | In distribution | |
| UL-0107 | In distribution | |
| DS-0236 | In distribution | |
| CS-0118 | In distribution | |
| CT-0242 | In distribution | |
| CT-0240 | In distribution | |
| CS-0148 | In distribution | |
| CS-0132 | In distribution | |
| UL-0109 | In distribution | |
| CS-0326 | In distribution | |
| DS-0212 | In distribution | |
| CS-0138 | In distribution | |
| UL-0104 | Withdrawn | |
| HS-0215 | Withdrawn | |
| ML-0506 | Withdrawn | |
| UL-0105 | 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
5 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 |
|---|---|---|---|---|---|---|---|
| Tedan Surgical Innovations, Inc. | UDI-DI | 2020-05-15 | Class II | Packaging change control | Lack of pouch seal. Product is labelled as sterile. | 1965 screws (packaged into 393 boxes) – [5 screws per box] | 2022-09-08 |
| Tedan Surgical Innovations, Inc. | UDI-DI | 2020-05-15 | Class II | Packaging change control | Lack of pouch seal. Product is labelled as sterile. | 1965 screws (packaged into 393 boxes) – [5 screw per box] | 2022-09-08 |
| Tedan Surgical Innovations, Inc. | UDI-DI | 2020-05-15 | Class II | Packaging change control | Lack of pouch seal. Product is labelled as sterile. | 730 screws (packaged into 146 boxes) – [5 screws per box] | 2022-09-08 |
| Tedan Surgical Innovations, Inc. | UDI-DI | 2020-05-15 | Class II | Packaging change control | Lack of pouch seal. Product is labelled as sterile. | 495 screws (packaged into 99 boxes) – [5 screws per box] | 2022-09-08 |
| Tedan Surgical Innovations, Inc. | UDI-DI | 2020-05-15 | Class II | Packaging change control | Lack of pouch seal. Product is labelled as sterile. | 340 screws (packaged into 68 boxes) – [5 screws per box] | 2022-09-08 |
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.