Drills, Burrs, Trephines & Accessories (Simple, Powered)
1.7 mm x 11.9 mm Twist Drill with Depth Stop, Aesculap max. 60,000 RPM. Use with SHORT-HD-G1, SHORT-HD Attachments.
3manufacturers in China registered for this device type
514catalogue 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) | K042783 |
| Record published | 2018-02-05 |
| Record revised | 2025-10-01 (version 10) |
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 |
| Storage | Storage environment temperature -40 to 70 °C; Handling environment temperature -40 to 70 °C; Handling environment humidity 10 to 95 % RH; Storage environment humidity 10 to 95 % RH |
| Distribution end date | 2026-06-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 310.133 | In distribution | |
| 03.000.044S | In distribution | |
| 03.000.006S | In distribution | |
| 317.58 | In distribution | |
| SD310.172 | In distribution | |
| 03.000.094S | In distribution | |
| 03.000.140S | In distribution | |
| 05.001.044 | In distribution | |
| 03.000.237S | In distribution | |
| 03.000.040S | In distribution | |
| 03.000.115S | In distribution | |
| 05.001.103 | In distribution | |
| 03.000.178S | In distribution | |
| 03.000.235S | In distribution | |
| 03.000.122S | In distribution | |
| 310.139 | In distribution | |
| 03.000.309S | In distribution | |
| 316.652 | In distribution | |
| 03.000.022S | In distribution | |
| 316.28 | In distribution | |
| 03.000.334S | In distribution | |
| 03.000.240S | In distribution | |
| 03.000.043S | In distribution | |
| 03.000.087S | In distribution | |
| 316.114 | In distribution | |
| 317.78 | In distribution | |
| 03.000.138S | In distribution | |
| MA-15S | In distribution | |
| 03.000.015S | In distribution | |
| 03.000.005S | In distribution | |
| M-4B-G1 | In distribution | |
| 03.000.124S | In distribution | |
| 03.000.342S | In distribution | |
| 03.503.124 | In distribution | |
| 03.000.086S | In distribution | |
| M-5DX-G1 | In distribution | |
| SD03.503.314 | In distribution | |
| 03.000.004S | In distribution | |
| 03.000.017S | In distribution | |
| 03.000.320S | In distribution | |
| 316.624 | In distribution | |
| 05.001.037 | In distribution | |
| SD317.071 | In distribution | |
| E-FP | In distribution | |
| 03.000.033S | In distribution | |
| 317.24 | In distribution | |
| 03.000.156S | In distribution | |
| 03.000.126S | In distribution | |
| 03.000.016S | In distribution | |
| 03.000.073S | In distribution | |
| 03.000.034S | In distribution | |
| 03.000.230S | In distribution | |
| 03.000.331S | In distribution | |
| 316.626 | In distribution | |
| M-4DX-G1 | In distribution | |
| 05.001.006 | In distribution | |
| 03.000.314S | In distribution | |
| 03.000.337S | In distribution | |
| 05.001.049 | In distribution | |
| 03.000.076S | In distribution | |
| 317.16 | In distribution | |
| 03.000.067S | In distribution | |
| 05.001.030 | In distribution | |
| 03.000.326S | In distribution | |
| M-8NS-G1 | In distribution | |
| 03.000.095S | In distribution | |
| 05.001.036 | In distribution | |
| 05.001.002 | In distribution | |
| 317.74 | In distribution | |
| 03.000.116S | In distribution | |
| 05.001.066 | In distribution | |
| 317.26 | In distribution | |
| 03.000.148S | In distribution | |
| 310.136 | In distribution | |
| M-5B-G1 | In distribution | |
| 310.137 | In distribution | |
| 316.452 | In distribution | |
| 03.000.032S | In distribution | |
| 03.000.038S | In distribution | |
| 03.000.172S | In distribution | |
| 310.134 | In distribution | |
| 317.76 | In distribution | |
| 05.001.185 | In distribution | |
| 03.000.078S | In distribution | |
| 316.38 | In distribution | |
| 03.000.013S | In distribution | |
| SD03.503.306 | In distribution | |
| MA-15C | In distribution | |
| 03.000.315S | In distribution | |
| 03.000.011S | In distribution | |
| MA15-8NS | In distribution | |
| 05.001.046 | In distribution | |
| 316.33 | In distribution | |
| 310.138 | In distribution | |
| 03.000.301S | In distribution | |
| 03.000.300S | In distribution | |
| 03.000.020S | In distribution | |
| 03.000.090S | In distribution | |
| MA-D20 | Withdrawn | |
| S-8ND-G1 | Withdrawn | |
| L-6DX-20-G1 | Withdrawn | |
| MA-10S | Withdrawn | |
| M-6B-G1 | Withdrawn | |
| S-4OV-G1 | Withdrawn | |
| M-35SDC-G1 | Withdrawn | |
| L-4OV-G1 | Withdrawn | |
| L-7DRC-11-G1 | Withdrawn | |
| L-35DR-G1 | Withdrawn | |
| L-5OV-G1 | Withdrawn | |
| S-1R-G1 | Withdrawn | |
| LHD-LS9-5-G1 | Withdrawn | |
| MHD-6B-G1 | Withdrawn | |
| M-8N-18-G1 | Withdrawn | |
| MHD-17DD-G1 | Withdrawn | |
| MHD-8NS-M-G1 | Withdrawn | |
| M-45DRMDX-G1 | Withdrawn | |
| L-56OV-G1 | Withdrawn | |
| S-5D-2-G1 | Withdrawn | |
| L-CRN-S-G1 | Withdrawn | |
| S-35SB-G1 | Withdrawn | |
| L-8BA-G1 | Withdrawn | |
| SHD-6R-G1 | Withdrawn | |
| L-6B-G1 | Withdrawn | |
| S-25SDC-G1 | Withdrawn | |
| S-3SB-G1 | Withdrawn | |
| XLHD-6B-G1 | Withdrawn | |
| S-3SB-C-G1 | Withdrawn | |
| S-3SBT-G1 | Withdrawn | |
| SHD-75AC-A-G1 | Withdrawn | |
| L-5BA-G1 | Withdrawn | |
| M-6AC-G1 | Withdrawn | |
| M-4D-G1 | Withdrawn | |
| S-7B-C-14F-G1 | Withdrawn | |
| L-3SB-4-G1 | Withdrawn | |
| XLHD-51C-G1 | Withdrawn | |
| MA19-3SB | Withdrawn | |
| L-5B-G1 | Withdrawn | |
| LHD-5DRM-L-G1 | Withdrawn | |
| L-3SDC-G1 | Withdrawn | |
| S-4BT-G1 | Withdrawn | |
| L-4DRM-G1 | Withdrawn | |
| S-62BE-G1 | Withdrawn | |
| MA15-2SB | Withdrawn | |
| L-4B-4-G1 | Withdrawn | |
| M-6B-C-G1 | Withdrawn | |
| M-1B-G1 | Withdrawn | |
| S-6P-G1 | Withdrawn | |
| S-3B-4-G1 | Withdrawn | |
| M-3D-G1 | Withdrawn | |
| L-5B-4-G1 | Withdrawn | |
| S-8DC-G1 | Withdrawn | |
| A-CRN-S-4-G1 | Withdrawn | |
| S-4DX-20-G1 | Withdrawn | |
| L-CRN-G1 | Withdrawn | |
| M-5B-27-G1 | Withdrawn | |
| S-5BA-G1 | Withdrawn | |
| M-58OV-G1 | Withdrawn | |
| MA19-2SB | Withdrawn | |
| M-5B-12F-G1 | Withdrawn | |
| S-1SB-G1 | Withdrawn | |
| M-4OV-G1 | Withdrawn | |
| M-15SDC-G1 | Withdrawn | |
| M-3DC-G1 | Withdrawn | |
| L-8NSDC-G1 | Withdrawn | |
| L-2SB-G1 | Withdrawn | |
| SHD-8NS-G1 | Withdrawn | |
| S-2433TD-G1 | Withdrawn | |
| L-4D-G1 | Withdrawn | |
| M-1R-G1 | Withdrawn | |
| S-35B-G1 | Withdrawn | |
| M-5B-4-G1 | Withdrawn | |
| M-7B-G1 | Withdrawn | |
| MA10-25SB | Withdrawn | |
| S-7B-C-G1 | Withdrawn | |
| L-6DC-G1 | Withdrawn | |
| S-35D-G1 | Withdrawn | |
| MIA16-6DC-G1 | Withdrawn | |
| S-1DC-G1 | Withdrawn | |
| M-2D-G1 | Withdrawn | |
| L-4B-C-G1 | Withdrawn | |
| S-5DX-G1 | Withdrawn | |
| L-4DX-G1 | Withdrawn | |
| MHD-62DRM-G1 | Withdrawn | |
| M-1SD-G1 | Withdrawn | |
| SHD-5B-G1 | Withdrawn | |
| S-5D-G1 | Withdrawn | |
| M-2DC-G1 | Withdrawn | |
| S-15B-G1 | Withdrawn | |
| S-4DRM-G1 | Withdrawn | |
| S-15SB-G1 | Withdrawn | |
| S-5D-100-G1 | Withdrawn | |
| S-2D-G1 | Withdrawn | |
| MA15-8N | Withdrawn | |
| MIA16-4DC-G1 | Withdrawn | |
| L-7AC-G1 | Withdrawn | |
| S-6D-100-G1 | Withdrawn | |
| P-CRN-4-G1 | Withdrawn | |
| M-4B-27-G1 | Withdrawn | |
| S-35SD-G1 | Withdrawn | |
| ADG-155-G1 | Withdrawn | |
| MA-15ST | Withdrawn | |
| S-8NS-M-G1 | Withdrawn | |
| XLHD-5B-G1 | Withdrawn | |
| L-8NSD-G1 | Withdrawn | |
| MHD-16CT-G1 | Withdrawn | |
| S-7IP-G1 | Withdrawn | |
| LHD-47-5-G1 | Withdrawn | |
| XLHD-7B-G1 | Withdrawn | |
| S-06SD-G1 | Withdrawn | |
| L-6DX-G1 | Withdrawn | |
| MHD-25R-G1 | Withdrawn | |
| SHD-25R-G1 | Withdrawn | |
| S-25SD-G1 | Withdrawn | |
| S-15DRMC-L-G1 | Withdrawn | |
| S-2B-G1 | Withdrawn | |
| L-8DX-G1 | Withdrawn | |
| S-6B-G1 | Withdrawn | |
| S-1B-G1 | Withdrawn | |
| S-6DX-20-G1 | Withdrawn | |
| S-5DC-G1 | Withdrawn | |
| S-2SB-C-G1 | Withdrawn | |
| M-2SB-G1 | Withdrawn | |
| M-4DRM-G1 | Withdrawn | |
| M-2SD-G1 | Withdrawn | |
| S-2SB-C-8F-G1 | Withdrawn | |
| S-5DC-40-G1 | Withdrawn | |
| MHD-97B-G1 | Withdrawn | |
| S-05SD-G1 | Withdrawn | |
| M-56OV-G1 | Withdrawn | |
| L-3SD-G1 | Withdrawn | |
| S-1506TD-G1 | Withdrawn | |
| L-7B-G1 | Withdrawn | |
| S-2SD-120-G1 | Withdrawn | |
| M-05D-G1 | Withdrawn | |
| S-25DC-G1 | Withdrawn | |
| MIA16-8NSM-G1 | Withdrawn | |
| LHD-5DRM12-G1 | Withdrawn | |
| MIA16-4D-G1 | Withdrawn | |
| S-7B-G1 | Withdrawn | |
| M-2SDC-G1 | Withdrawn | |
| L-6DRC-G1 | Withdrawn | |
| L-8NS-G1 | Withdrawn | |
| MA19-8N-18 | Withdrawn | |
| MA10-2SB | Withdrawn | |
| S-2SB-4-G1 | Withdrawn | |
| MHD-19CT-G1 | Withdrawn | |
| MA19-8NS | Withdrawn | |
| M-8NSD-G1 | Withdrawn | |
| L-1SD-G1 | Withdrawn | |
| L-5DC-G1 | Withdrawn |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| Midas Rex MR8 | Medtronic PS Medical | 59 |
Showing 12 of 269. All products under Drills, Burrs, Trephines & Accessories (Simple, Powered)
Recalls Naming This Product
99 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 |
|---|---|---|---|---|---|---|---|
| Synthes (USA) Products LLC | 510(k) number | 2016-11-01 | Class II | Under Investigation by firm | Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit. | 84 units | 2017-06-01 |
| 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. | 19 | 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. | 17 | 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. | 1 | 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. | 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 | 2016-06-24 | Class I | Device Design | There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst. | 1,833 devices (05.001.024 and 05.001.108) | 2018-06-09 |
| THE Anspach Effort, Inc. | 510(k) number | 2016-06-24 | Class I | Device Design | There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst. | 1,833 devices (05.001.024 and 05.001.108) | 2018-06-09 |
| Synthes (USA) Products LLC | 510(k) number | 2016-05-31 | Class II | Labeling False and Misleading | DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard. | 19 units | 2017-02-02 |
| 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 |
Showing 40 of 99.
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.