Ascent
Tensioner AND Crimper, Ascent Poct
7manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (4), Guangdong (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Tianbo First AID Product Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 66 |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan | Guangdong | Repacker / relabeller | 62 |
| Firstar Healthcare Company Limited (Guangzhou) | Guangzhou | Guangdong | Contract manufacturer | 57 |
| Yiwu Ori-Power Medtech Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 46 |
| H&K International Trade Limited (China) | Jinhua | Zhejiang | Contract manufacturer | 29 |
| Wenzhou Zhusi Medical Supplies Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 27 |
| Yancheng Trancom First AID Supplies Industrial Co., Ltd. | Yangcheng | Jiangsu | Contract manufacturer | 25 |
Record
| Listed by | Orthofix US LLC, United States |
|---|---|
| FDA product code | HXQ |
| Device type | Crimper, Pin |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-03-19 |
| Record revised | 2026-02-20 (version 4) |
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 |
|---|---|---|
| 65-1068 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Link Instruments – Fixation instruments | Waldemar Link GmbH & Co. KG | 12 |
| Crimper, Pin | Synthes Gmbh | 4 |
| Tryptik 2 C-Plate Instrumentation | Spineart SA | 4 |
| Lospa IS Spinal System | Corentec Co., Ltd. | 4 |
| Spark – Instruments | Waldemar Link GmbH & Co. KG | 4 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 3 |
| TrabecuLink Femoral and Tibial Cone – Instruments | Waldemar Link GmbH & Co. KG | 3 |
| Cable-Ready® | Zimmer, Inc. | 2 |
| Endo-Model Knee System – Instruments | Waldemar Link GmbH & Co. KG | 2 |
| Chiroklip wire protector 2 pack blister/box with 25 blisters | Osteotec Limited | 1 |
| Cervical Plating System | Signus Medizintechnik Gmbh | 1 |
| Bone-Tendon-Bone | Biomet Orthopedics | 1 |
Showing 12 of 20. All products under Crimper, Pin
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.