Motor, Drill, Electric
5 mm x 20 mm Graft Harvesting Blade. Use with E-SAGITTAL, B- SAGITTAL, and MM-SAGITTAL Saws.
1manufacturer
168catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Rainbow Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 12 |
Record
| Listed by | Anspach Effort, The |
|---|---|
| FDA product code | HBC |
| Device type | Motor, Drill, Electric |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4360 |
| 510(k) | K011444 |
| Record published | 2016-09-09 |
| Record revised | 2024-09-19 (version 7) |
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 | 2024-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| QD14-8N | Withdrawn | |
| MRA-8S | Withdrawn | |
| QD8-5DX | Withdrawn | |
| QD14-8N-18 | Withdrawn | |
| LS-3405 | Withdrawn | |
| MS-3231 | Withdrawn | |
| M-4B | Withdrawn | |
| QD8-2SDC | Withdrawn | |
| S-5D | Withdrawn | |
| QD8-4DX | Withdrawn | |
| S-3SB | Withdrawn | |
| L-5DC | Withdrawn | |
| S-6DX | Withdrawn | |
| QD8-15SDC | Withdrawn | |
| L-6DC | Withdrawn | |
| SIL-1 | Withdrawn | |
| A-CRN-M | Withdrawn | |
| M-4D | Withdrawn | |
| SIL-14 | Withdrawn | |
| S-35SD | Withdrawn | |
| S-4DX | Withdrawn | |
| QD8-3SD | Withdrawn | |
| QD8-6DC | Withdrawn | |
| QD8-1SDC | Withdrawn | |
| QD11-5OV | Withdrawn | |
| MR-0520 | Withdrawn | |
| L-3SDC | Withdrawn | |
| QD8-8N-18 | Withdrawn | |
| S-1506TD-M | Withdrawn | |
| QD11-6B | Withdrawn | |
| M-3B | Withdrawn | |
| S-6R | Withdrawn | |
| MDA-2SB | Withdrawn | |
| QD11-5B-A | Withdrawn | |
| S-6P | Withdrawn | |
| S-5B | Withdrawn | |
| MO-3002 | Withdrawn | |
| QD8-5DC | Withdrawn | |
| L-5D | Withdrawn | |
| S-9AC | Withdrawn | |
| QD14-5DC | Withdrawn | |
| MO-3003 | Withdrawn | |
| MDA-4D | Withdrawn | |
| M-8BA | Withdrawn | |
| SIL-10 | Withdrawn | |
| S-15SB | Withdrawn | |
| S-2DC | Withdrawn | |
| S-4OV | Withdrawn | |
| MS-3101C | Withdrawn | |
| S-15D | Withdrawn | |
| QD11-6DC | Withdrawn | |
| MS-3106 | Withdrawn | |
| QD14-4DC | Withdrawn | |
| QD8-25SD | Withdrawn | |
| S-2SB | Withdrawn | |
| ORNG-1275 | Withdrawn | |
| QD8-25SDC | Withdrawn | |
| SHD-1504TD | Withdrawn | |
| S-2SDC | Withdrawn | |
| LS-3406 | Withdrawn | |
| L-1SD | Withdrawn | |
| M-1R | Withdrawn | |
| L-1SB | Withdrawn | |
| SIL-7-9 | Withdrawn | |
| SIL-2 | Withdrawn | |
| SIL-17-4CX | Withdrawn | |
| MS-3101 | Withdrawn | |
| SIL-17-5CX | Withdrawn | |
| E-HC | Withdrawn | |
| QD11-3SB | Withdrawn | |
| QD11-5DC | Withdrawn | |
| L-6DX | Withdrawn | |
| MDA-3SD | Withdrawn | |
| MR-14006 | Withdrawn | |
| L-8BA | Withdrawn | |
| M-2DC | Withdrawn | |
| QD8-5B | Withdrawn | |
| QD8-2SD | Withdrawn | |
| A-CRN-S | Withdrawn | |
| M-8NS | Withdrawn | |
| QD8-05SD | Withdrawn | |
| QD11-4DX | Withdrawn | |
| S-2D | Withdrawn | |
| QD8-05B | Withdrawn | |
| S-1B | Withdrawn | |
| SIL-24 | Withdrawn | |
| SHD-25DD | Withdrawn | |
| QD8-4OV | Withdrawn | |
| M-1SB | Withdrawn | |
| M-5B | Withdrawn | |
| SIL-23 | Withdrawn | |
| S-8N | Withdrawn | |
| S-68DRMDC | Withdrawn | |
| MO-3225 | Withdrawn | |
| M-2D | Withdrawn | |
| S-1R | Withdrawn | |
| M-1DC | Withdrawn | |
| QD8-8NS | Withdrawn | |
| S-8N-18 | Withdrawn | |
| SA-JLATCH | Withdrawn | |
| SIL-1510 | Withdrawn | |
| SIL-17-4 | Withdrawn | |
| S-3SDC | Withdrawn | |
| QD8-4OVD | Withdrawn | |
| QD14-6DX | Withdrawn | |
| M-1B | Withdrawn | |
| MR-0500 | Withdrawn | |
| QD8-3SDC | Withdrawn | |
| L-CRN-S | Withdrawn | |
| ADG-10 | Withdrawn | |
| SIL-15 | Withdrawn | |
| ORNG-8-18 | Withdrawn | |
| QD11-3SDC | Withdrawn | |
| QD8-25SB | Withdrawn | |
| MS-3515 | Withdrawn | |
| P-CRN-M | Withdrawn | |
| SIL-5 | Withdrawn | |
| MR-0560 | Withdrawn | |
| S-8ND | Withdrawn | |
| SIL-38 | Withdrawn | |
| M-1D | Withdrawn | |
| SIL-6 | Withdrawn | |
| QD14-8ND | Withdrawn | |
| QD11-6DX | Withdrawn | |
| S-2B | Withdrawn | |
| QD11-5DRM | Withdrawn | |
| QD8-3SB | Withdrawn | |
| QD11-4OV | Withdrawn | |
| SIL-17-3 | Withdrawn | |
| QD8-1SD | Withdrawn | |
| SIL-9 | Withdrawn | |
| MS-3104 | Withdrawn | |
| CRANI-A-01 | Withdrawn | |
| S-7B | Withdrawn | |
| MDA-8N-18 | Withdrawn | |
| S-05D | Withdrawn | |
| MIA16-8NS | Withdrawn | |
| QD14-6D | Withdrawn | |
| MO-3515 | Withdrawn | |
| M-6P | Withdrawn | |
| S-9B | Withdrawn | |
| M-6B | Withdrawn | |
| QD8-5BA | Withdrawn | |
| S-1D | Withdrawn | |
| L-5B | Withdrawn | |
| MDA-2SD | Withdrawn | |
| QD14-5B-A | Withdrawn | |
| S-8NS | Withdrawn | |
| S-3D | Withdrawn | |
| SIL-47 | Withdrawn | |
| QD11-5DX | Withdrawn | |
| QD8-5OV | Withdrawn | |
| QD11-5B | Withdrawn | |
| S-5DC | Withdrawn | |
| L-4OV | Withdrawn | |
| S-6PD | Withdrawn | |
| QD14-2SD | Withdrawn | |
| SIL-17-6 | Withdrawn | |
| MS-3102 | Withdrawn | |
| QD8-3SD-100 | Withdrawn | |
| SIL-4 | Withdrawn | |
| QD14-5B | Withdrawn | |
| S-5DX | Withdrawn | |
| LS-3408 | Withdrawn | |
| QD8-6B | Withdrawn | |
| MS-3240 | Withdrawn | |
| P-CRN | Withdrawn | |
| M-3DC | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NSK Sterile Burs/Drills | Nakanishi Inc. | 447 |
| Primado2 | Nakanishi Inc. | 96 |
| Elan 4 | Aesculap AG | 39 |
| Midas REX® | Medtronic Powered Surgical Solutions | 29 |
| NSK Sterile Blades | Nakanishi Inc. | 24 |
| Motor, Drill, Electric | Synthes Gmbh | 22 |
| Aesculap | Aesculap AG | 14 |
| SSG10 | Saeshin Precision Co., Ltd. | 11 |
| Traus | Saeshin Precision Co., Ltd. | 9 |
| Midas Rex MR8 | Medtronic Powered Surgical Solutions | 7 |
| Eccos | Aesculap AG | 7 |
| Motor, Drill, Electric | Medtronic Xomed, Inc. | 6 |
Showing 12 of 75. All products under Motor, Drill, Electric
Recalls Naming This Product
40 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 | 2022-12-07 | Class II | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the | 6059 units in total | |
| THE Anspach Effort, Inc. | 510(k) number | 2022-12-07 | Class II | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the | 6059 units in total | |
| THE Anspach Effort, Inc. | 510(k) number | 2022-12-07 | Class II | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the | 6059 units in total | |
| THE Anspach Effort, Inc. | 510(k) number | 2022-12-07 | Class II | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the | 6059 units in total | |
| THE Anspach Effort, Inc. | 510(k) number | 2022-12-07 | Class II | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the | 6059 units in total | |
| THE Anspach Effort, Inc. | 510(k) number | 2022-12-07 | Class II | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the | 6059 units in total | |
| THE Anspach Effort, Inc. | 510(k) number | 2022-12-07 | Class II | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the | 6059 units in total | |
| THE Anspach Effort, Inc. | 510(k) number | 2022-12-07 | Class II | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the | 6059 units in total | |
| THE Anspach Effort, Inc. | 510(k) number | 2022-12-07 | Class II | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the | 6059 units in total | |
| 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. | 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. | 207 | 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. | 32 | 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. | 158 | 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. | 293 | 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. | 320 | 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. | 22 | 2019-07-26 |
| THE Anspach Effort, Inc. | 510(k) number | 2013-05-06 | Class II | Unknown/Undetermined by firm | Product did not reach expected sterility assurance level | 183 | 2016-04-18 |
| THE Anspach Effort, Inc. | 510(k) number | 2012-11-28 | Class II | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. | 2 | 2014-08-07 |
| THE Anspach Effort, Inc. | 510(k) number | 2012-11-28 | Class II | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. | 6 | 2014-08-07 |
| THE Anspach Effort, Inc. | 510(k) number | 2012-11-28 | Class II | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. | 2 | 2014-08-07 |
| THE Anspach Effort, Inc. | 510(k) number | 2012-11-28 | Class II | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. | 9 | 2014-08-07 |
| THE Anspach Effort, Inc. | 510(k) number | 2012-11-28 | Class II | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. | 1 | 2014-08-07 |
| THE Anspach Effort, Inc. | 510(k) number | 2012-11-28 | Class II | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. | 2 | 2014-08-07 |
| THE Anspach Effort, Inc. | 510(k) number | 2012-11-28 | Class II | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. | 1 | 2014-08-07 |
| THE Anspach Effort, Inc. | 510(k) number | 2012-11-28 | Class II | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. | 5 | 2014-08-07 |
| THE Anspach Effort, Inc. | 510(k) number | 2012-11-28 | Class II | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. | 50 | 2014-08-07 |
| THE Anspach Effort, Inc. | 510(k) number | 2012-11-28 | Class II | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. | 1 | 2014-08-07 |
| THE Anspach Effort, Inc. | 510(k) number | 2012-11-28 | Class II | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. | 10 | 2014-08-07 |
| THE Anspach Effort, Inc. | 510(k) number | 2012-11-28 | Class II | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. | 20 | 2014-08-07 |
| THE Anspach Effort, Inc. | 510(k) number | 2012-11-28 | Class II | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. | 40 | 2014-08-07 |
| THE Anspach Effort, Inc. | 510(k) number | 2012-11-28 | Class II | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. | 19 | 2014-08-07 |
| THE Anspach Effort, Inc. | 510(k) number | 2012-11-28 | Class II | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. | 1 | 2014-08-07 |
| THE Anspach Effort, Inc. | 510(k) number | 2011-05-09 | Not classified | Employee error | The Anspach Effort, Inc., Palm Beach Gardens, FL, is recalling their Anspach Single Use, Sterile Bone Cutting Burrs, catalog numbers, IMRI-S-8NS-M, M-6P, QD8-4OVD, S-5B-4, and SIL-7-9, lot #’s C323023789, C403026551, C473028567, C403026563, | 5 | 2012-02-15 |
| THE Anspach Effort, Inc. | 510(k) number | 2011-05-09 | Not classified | Employee error | The Anspach Effort, Inc., Palm Beach Gardens, FL, is recalling their Anspach Single Use, Sterile Bone Cutting Burrs, catalog numbers, IMRI-S-8NS-M, M-6P, QD8-4OVD, S-5B-4, and SIL-7-9, lot #’s C323023789, C403026551, C473028567, C403026563, | 13 | 2012-02-15 |
| THE Anspach Effort, Inc. | 510(k) number | 2011-05-09 | Not classified | Employee error | The Anspach Effort, Inc., Palm Beach Gardens, FL, is recalling their Anspach Single Use, Sterile Bone Cutting Burrs, catalog numbers, IMRI-S-8NS-M, M-6P, QD8-4OVD, S-5B-4, and SIL-7-9, lot #’s C323023789, C403026551, C473028567, C403026563, | 17 | 2012-02-15 |
| THE Anspach Effort, Inc. | 510(k) number | 2011-05-06 | Class II | Labeling Change Control | Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and compliance | 2,020 | 2016-01-28 |
| THE Anspach Effort, Inc. | 510(k) number | 2011-03-31 | Class II | Pending | Cutter was longer than was stated on the label | 599 cutting burs | 2019-07-18 |
| THE Anspach Effort, Inc. | 510(k) number | 2011-03-17 | Not classified | Mixed-up of materials/components | The Anspach Effort, Palm Beach Gardens, FL, is recalling their Single Use, Sterile Bone Cutting Burrs, Catalog #, S-1504TD, Lot #s D363039140. D323038110, D293037349 and Catalog # TURQ-434-4, Lot #s D343038845, D323038131, due to the burr b | 599 | 2011-10-11 |
| THE Anspach Effort, Inc. | 510(k) number | 2011-03-17 | Not classified | Mixed-up of materials/components | The Anspach Effort, Palm Beach Gardens, FL, is recalling their Single Use, Sterile Bone Cutting Burrs, Catalog #, S-1504TD, Lot #s D363039140. D323038110, D293037349 and Catalog # TURQ-434-4, Lot #s D343038845, D323038131, due to the burr b | 29 units | 2011-10-11 |
| THE Anspach Effort, Inc. | 510(k) number | 2003-04-23 | Not classified | Other | Faulty component causing a malfunction which would unexpectedly shutdown the drill system and user may not be able to restart. | 24 | 2003-09-22 |
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.