EXT Break-Off Tool
Catalogue number 16301-7011, listed by Captiva Spine, Inc., United States, under Instrument, Bending Or Contouring. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
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 | Captiva Spine, Inc., United States |
|---|---|
| FDA product code | HXP |
| Device type | Instrument, Bending Or Contouring |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-07-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 16301-7011 | 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 |
| Tecomet | Tecomet, Inc. | 17 |
| 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 |
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.