Polaris 5.5 Spinal Fixation System
Trephine BIT, 5MM
6manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Shandong (1), Guangdong (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 |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
Record
| Listed by | Highridge Medical, LLC, United States |
|---|---|
| FDA product code | HWK |
| Device type | Trephine |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-12-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-501736 | In distribution | |
| 14-501737 | In distribution | |
| 14-501738 | In distribution | |
| 14-501735 | In distribution | |
| 14-501739 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ACE | Ace Surgical Supply Co., Inc. | 58 |
| Shukla Trephine S9TREPHINE | Shukla Medical | 42 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 40 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 28 |
| IdentiTi | Alphatec Spine, Inc. | 22 |
| Zoll-Dental | Zoll-Dental | 20 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 17 |
| Trephine | Synthes Gmbh | 15 |
| Trephine | KLS-Martin L.P. | 14 |
| Moreland | Depuy Orthopaedics, Inc. | 14 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 13 |
| Bradshaw Medical Inc. | Bradshaw Medical Inc. | 13 |
Showing 12 of 138. All products under Trephine
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.