Surgify Halo – 5.4 Mm – Medium
3 catalogue numbers from 100-54-TM (US), listed by Surgify Medical OY, Finland, under Drills, Burrs, Trephines & Accessories (Simple, Powered). 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
3catalogue numbers in this listing
4510(k) clearances naming this product code
19recalls on this code
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 | Surgify Medical OY, Finland |
|---|---|
| FDA product code | HBE |
| Device type | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4310 |
| Establishment | Manufacturer |
| Record published | 2024-12-20 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 100-54-TM (US) | In distribution | |
| 54.085.SHD.U1 | In distribution | |
| 54.085.SHD.H1 | In distribution |
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)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253627 | 2026-03-26 |
| K251433 | 2025-06-04 |
| K250380 | 2025-03-13 |
| K232684 | 2023-11-29 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason |
|---|---|---|---|---|---|
| Surgify Medical OY | UDI-DI | 2026-04-30 | Class II | Under Investigation by firm | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| Surgify Medical OY | UDI-DI | 2026-04-30 | Class II | Under Investigation by firm | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
Recalls
17 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-04-30 | Class II | Under Investigation by firm | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | 8 units |
| 2026-04-30 | Class II | Under Investigation by firm | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | |
| 2026-04-30 | Class II | Under Investigation by firm | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | |
| 2026-04-30 | Class II | Under Investigation by firm | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | 0 |
| 2026-04-30 | Class II | Under Investigation by firm | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | |
| 2026-04-30 | Class II | Under Investigation by firm | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | 53 units |
| 2026-04-30 | Class II | Under Investigation by firm | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | |
| 2026-04-30 | Class II | Under Investigation by firm | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | |
| 2026-04-30 | Class II | Under Investigation by firm | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | |
| 2026-04-30 | Class II | Under Investigation by firm | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | 112 units |
| 2026-04-30 | Class II | Under Investigation by firm | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | |
| 2026-04-30 | Class II | Under Investigation by firm | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | 15 units |
| 2026-04-30 | Class II | Under Investigation by firm | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | |
| 2026-04-30 | Class II | Under Investigation by firm | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | |
| 2026-04-30 | Class II | Under Investigation by firm | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | |
| 2026-04-30 | Class II | Under Investigation by firm | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | 0 |
| 2026-04-30 | Class II | Under Investigation by firm | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
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.