Tecomet
Bending Iron, Left, for 2.7mm & 3.5mm Plates
5manufacturers in China registered for this device type
17catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
Record
| Listed by | Tecomet, Inc., United States |
|---|---|
| FDA product code | HXP |
| Device type | Instrument, Bending Or Contouring |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-10-12 |
| Record revised | 2025-11-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KMPR1579 | In distribution | |
| 00481900300 | In distribution | |
| KMPR1585 | In distribution | |
| KMPR1580 | In distribution | |
| KMPR3078 | In distribution | |
| 47915 | In distribution | |
| 47916 | In distribution | |
| 00481900400 | In distribution | |
| 47919 | In distribution | |
| 45502 | In distribution | |
| 00481900200 | In distribution | |
| KMPR1586 | In distribution | |
| KMPR1587 | In distribution | |
| 00481900600 | In distribution | |
| KMPR1581 | In distribution | |
| KMPR1582 | In distribution | |
| 45501 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrument, Bending Or Contouring | Synthes Gmbh | 72 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 21 |
| Instrument, Bending Or Contouring | AAP Implantate AG | 10 |
| Kmedic | Teleflex Medical LLC | 10 |
| Bioplate® | Bioplate, Inc. | 9 |
| g Source | Gsource, LLC. | 7 |
| Ambler Surgical | Ambler Surgical, LLC | 6 |
| Tools – WFS | Trimed, Inc. | 6 |
| Generic Instruments | Trimed, Inc. | 6 |
| MaxLock | Tornier Inc. | 5 |
| Stille Wire Twisting and Holding Forceps | Stille AB | 5 |
| Tools – FPS | Trimed, Inc. | 5 |
Showing 12 of 154. All products under Instrument, Bending Or Contouring
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.