Drills, Burrs, Trephines & Accessories (Simple, Powered)
6.2 mm x 4.6 mm Fluted Drum, Side Cut Only. Use with QD8-G1, SHORT-G1, QD8, QD8-S, SHORT Attachments.
3manufacturers in China registered for this device type
49catalogue 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 | Anspach Effort, The |
|---|---|
| FDA product code | HBE |
| Device type | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4310 |
| 510(k) | K040076 |
| Record published | 2016-09-09 |
| Record revised | 2024-06-13 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Distribution end date | 2026-01-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MS-3100C | Withdrawn | |
| L-5DRC | Withdrawn | |
| MHD-25DD | Withdrawn | |
| MR-0580 | Withdrawn | |
| MR-0600 | Withdrawn | |
| S-62DRM-G1 | Withdrawn | |
| S-2SD-120 | Withdrawn | |
| M-7AC | Withdrawn | |
| L-5B-A-G1 | Withdrawn | |
| MS-3108 | Withdrawn | |
| LS-3407 | Withdrawn | |
| S-3SDCT | Withdrawn | |
| L-9B | Withdrawn | |
| S-5DC-40 | Withdrawn | |
| L-7DRC | Withdrawn | |
| M-35SDC | Withdrawn | |
| S-06SD | Withdrawn | |
| SHD-6DX | Withdrawn | |
| M-6DX | Withdrawn | |
| L-68DRMDX | Withdrawn | |
| LS-3411 | Withdrawn | |
| S-6DX-20 | Withdrawn | |
| IMRI-S-8NS-M | Withdrawn | |
| MO-3006 | Withdrawn | |
| MA19-4B | Withdrawn | |
| SHD-4840DS | Withdrawn | |
| MIA16-5DRM | Withdrawn | |
| QD11-3BA-A | Withdrawn | |
| IMRI-SHORT | Withdrawn | |
| IMRI-S-1R | Withdrawn | |
| MS-3225 | Withdrawn | |
| S-8NSD | Withdrawn | |
| MO-3105 | Withdrawn | |
| LS-3410 | Withdrawn | |
| S-4DX-20 | Withdrawn | |
| IMRI-SHD-6B | Withdrawn | |
| S-3SDC-50 | Withdrawn | |
| MR-0540 | Withdrawn | |
| LS-3409 | Withdrawn | |
| LS-3412 | Withdrawn | |
| QD8-5B-C-10F | Withdrawn | |
| MO-3001 | Withdrawn | |
| MDA-8NSDC | Withdrawn | |
| QD11-4DX-20 | Withdrawn | |
| IMRI-SHORT-HD | Withdrawn | |
| LHD-6B | Withdrawn | |
| MO-3005 | Withdrawn | |
| S-15SDC | Withdrawn | |
| MS-3105 | 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)
Recalls Naming This Product
93 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| THE Anspach Effort, Inc. | 510(k) number | 2016-10-06 | Class II | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. | 209 | 2019-07-26 |
| THE Anspach Effort, Inc. | 510(k) number | 2016-10-06 | Class II | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. | 821 | 2019-07-26 |
| THE Anspach Effort, Inc. | 510(k) number | 2016-10-06 | Class II | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. | 439 | 2019-07-26 |
| THE Anspach Effort, Inc. | 510(k) number | 2016-10-06 | Class II | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. | 462 | 2019-07-26 |
| THE Anspach Effort, Inc. | 510(k) number | 2016-08-26 | Class II | Device Design | Product Code L- 7B-G1 was inadvertently released off of hold status and the affected products were distributed. | 177 | 2017-11-29 |
| THE Anspach Effort, Inc. | 510(k) number | 2016-08-26 | Class II | Device Design | The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503. | 88 | 2017-11-29 |
| THE Anspach Effort, Inc. | 510(k) number | 2016-08-26 | Class II | Device Design | The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503. | 63 | 2017-11-29 |
| THE Anspach Effort, Inc. | 510(k) number | 2016-08-26 | Class II | Device Design | The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503. | 69 | 2017-11-29 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 65 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 138 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 88 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 177 tools | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 227 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 115 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 110 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 110 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 91 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 72 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 353 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 69 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 142 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 178 | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 92 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 79 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 103 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 95 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 70 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 189 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 75 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 95 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 88 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 118 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 78 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 70 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 796 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 99 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 246 | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 178 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 70 tools. | 2016-08-25 |
| THE Anspach Effort, Inc. | 510(k) number | 2015-04-13 | Class II | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposur | 80 tools. | 2016-08-25 |
Showing 40 of 93.
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.