Motor, Surgical Instrument, Ac-Powered
20.2 cm Heavy Duty Extra Long Attachment. Use with XMax, eMax Systems.
7manufacturers in China registered for this device type
29catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (5), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Shenzhen Jinlichang Electronic Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
| Shenzhen Soga Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Ningbo Advan Electrical Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | GEY |
| Device type | Motor, Surgical Instrument, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K080802 |
| Record published | 2016-12-31 |
| 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 | Handling environment temperature -40 to 70 °C; Storage environment humidity 10 to 95 % RH; Storage environment temperature -40 to 70 °C; Handling environment humidity 10 to 95 % RH |
| Distribution end date | 2026-06-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 530.750 | In distribution | ||
| 05.001.201 | In distribution | ||
| 511.777 | In distribution | ||
| 05.001.179.05S | 5 | In distribution | |
| 530.783 | In distribution | ||
| 05.001.240 | In distribution | ||
| 530.782 | In distribution | ||
| 530.731 | In distribution | ||
| 530.710 | In distribution | ||
| 511.773 | In distribution | ||
| 530.705 | In distribution | ||
| 530.784 | In distribution | ||
| 530.715 | In distribution | ||
| 511.776 | In distribution | ||
| 530.780 | In distribution | ||
| 511.771 | In distribution | ||
| 530.730 | In distribution | ||
| 530.741 | In distribution | ||
| 530.791 | In distribution | ||
| 511.774 | In distribution | ||
| 530.796 | In distribution | ||
| 511.770 | In distribution | ||
| 05.001.241 | In distribution | ||
| 530.760 | In distribution | ||
| SC2102 | Withdrawn | ||
| 530.790 | Withdrawn | ||
| SC2101 | Withdrawn | ||
| XL-HD | Withdrawn | ||
| MA10-3SD | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| De Soutter Medical | DE Soutter Medical Ltd. | 1,481 |
| HI-Line XS | Aesculap AG | 169 |
| Zaguar | Imedicom Co., Ltd. | 131 |
| Elan 4 | Aesculap AG | 107 |
| Aesculap | Aesculap AG | 72 |
| HI-Line | Aesculap AG | 53 |
| Motor, Surgical Instrument, Ac-Powered | Anspach Effort, The | 37 |
| Zimmer Biomet™ | Zimmer Surgical, Inc. | 29 |
| HI-Line XXS | Aesculap AG | 22 |
| Motor, Surgical Instrument, Ac-Powered | Smith & Nephew, Inc. | 20 |
| Eccos | Aesculap AG | 11 |
| Motor, Surgical Instrument, Ac-Powered | Richard Wolf Gmbh | 10 |
Showing 12 of 149. All products under Motor, Surgical Instrument, Ac-Powered
Recalls Naming This Product
27 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 | 2013-12-17 | Class II | Process design | Some carbide cutting burr fractured during use. | 28,562 total of all products in this recall | 2016-05-09 |
| THE Anspach Effort, Inc. | 510(k) number | 2013-12-17 | Class II | Process design | Some carbide cutting burr fractured during use. | 28,562 total of all products in this recall | 2016-05-09 |
| THE Anspach Effort, Inc. | 510(k) number | 2013-12-17 | Class II | Process design | Some carbide cutting burr fractured during use. | 28,562 total of all products in this recall | 2016-05-09 |
| THE Anspach Effort, Inc. | 510(k) number | 2013-12-17 | Class II | Process design | Some carbide cutting burr fractured during use. | 28,562 products for the entire recall | 2016-05-09 |
| 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. | 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. | 3 | 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. | 21 | 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. | 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. | 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. | 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. | 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. | 12 | 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. | 4 | 2014-08-07 |
| THE Anspach Effort, Inc. | 510(k) number | 2012-01-09 | Class II | Nonconforming Material/Component | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due to the Foot Control Cable lacking the shield connection from the cable to the connector body. | 16 units | 2014-09-16 |
| THE Anspach Effort, Inc. | 510(k) number | 2012-01-09 | Class II | Nonconforming Material/Component | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due to the Foot Control Cable lacking the shield connection from the cable to the connector body. | 41 units | 2014-09-16 |
| THE Anspach Effort, Inc. | 510(k) number | 2012-01-09 | Class II | Nonconforming Material/Component | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due to the Foot Control Cable lacking the shield connection from the cable to the connector body. | 10 units | 2014-09-16 |
| 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 | 2009-08-13 | Not classified | Device Design | The Anspach Effort, Inc. is recalling the Foot Control/ Foot Pedal for SC2000 and SC2100 Powered, simple cranial drills, burrs, trephines, and accessories. The Foot Control Cables lacks the shield connection from the cable to the connector | 14 | 2010-01-05 |
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.