Anspach Helix™
ANSPACH HELIX™ 3.5 mm Fluted Ball, Standard Length
3manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (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 |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | HBE |
| Device type | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4310 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K183545 |
| Record published | 2019-12-11 |
| Record revised | 2026-01-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2026-01-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S-35SB-HX-G1 | Withdrawn | |
| S-3SB-HX-G1 | Withdrawn | |
| M-3B-HX-G1 | Withdrawn | |
| L-6B-HX-G1 | Withdrawn | |
| M-6B-HX-G1 | Withdrawn | |
| M-4B-HX-G1 | Withdrawn | |
| L-2B-HX-G1 | Withdrawn | |
| S-5B-HX-G1 | Withdrawn | |
| L-5B-HX-G1 | Withdrawn | |
| S-25B-HX-G1 | Withdrawn | |
| M-7B-HX-G1 | Withdrawn | |
| M-2B-HX-G1 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Midas REX MR8 | Medtronic Powered Surgical Solutions | 1,006 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Stryker GmbH | 948 |
| Elan 4 | Aesculap AG | 529 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Synthes Gmbh | 514 |
| Zethon | Zethon Ltd | 237 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Stryker Leibinger Gmbh & Co. KG | 220 |
| Midas Rex® | Medtronic Powered Surgical Solutions | 167 |
| HiCUT Burs | Adeor Medical AG | 90 |
| Phasor | Phasor Health, LLC | 80 |
| Traumaone System | Biomet Microfixation | 62 |
| Midas REX Microsaws | Medtronic Powered Surgical Solutions | 60 |
| Mids REX MR8 | Medtronic Powered Surgical Solutions | 59 |
Showing 12 of 269. All products under Drills, Burrs, Trephines & Accessories (Simple, Powered)
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.