Kmedic
3 catalogue numbers from IPN013627, listed by Teleflex Medical LLC, United States, under Brace, Drill. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Shandong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Shandong Banbanni Electronic Technology Co., Ltd. | Linyi | Shandong | Contract manufacturer | 2 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | HXY |
| Device type | Brace, Drill |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-15 |
| Record revised | 2026-02-05 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | manufacturing date |
| Sizes | Length 13 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN013627 | Length 13 cm | In distribution |
| IPN013628 | Length 13 cm | In distribution |
| IPN013626 | Length 13 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 40 |
| Aesculap | Aesculap AG | 14 |
| Volition Plating System | Ortho Solutions Inc | 11 |
| OrthoSolutions ‘System26’ Bone Screws | Ortho Solutions Inc | 7 |
| COGNiTiON™ Staple System | Ortho Solutions Inc | 6 |
| Spider Cervical Plating System | Xtant Medical Holdings, Inc. | 5 |
| Biopsybell | Biopsybell SRL | 5 |
| Acculan II | Aesculap AG | 4 |
| Plasmafit | Aesculap AG | 4 |
| Cosy | Signus Medizintechnik Gmbh | 4 |
| Aranax Anterior Cervical Plating System | Xtant Medical Holdings, Inc. | 3 |
| 4-Hole Drill Guide | Captiva Spine, Inc. | 3 |
Showing 12 of 48. All products under Brace, Drill
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.