Medtronic (Changzhou) Medical Devices Technology Co., Ltd.
Registered establishment in Changzhou, Jiangsu, China. 53 device types.
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Awl, Rasp and 51 other device types. Its earliest product listing with the FDA dates from 1978.
Registration
| Registered name | Medtronic (Changzhou) Medical Devices Technology Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3005677016 |
| FEI number | 3005677016 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 美敦力（常州）医疗器械科技有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | Building #3, 11 ChangJiang North Road, Xinbei District |
| Postal code | 213022 |
| Country | China |
What It Makes
Clearances
No clearance names Medtronic (Changzhou) Medical Devices Technology Co., Ltd. as applicant. 41 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K254165 | 2026-01-21 | NKG | Special | Medtronic Sofamor Danek USA, Inc. |
| K253129 | 2025-10-24 | NKG | Special | Medtronic Sofamor Danek USA, Inc. |
| K223494 | 2023-01-23 | NKB | Traditional | Medtronic, Inc. |
| K222383 | 2022-09-29 | OLO | Special | Medtronic Sofamor Danek USA, Inc. |
| K221180 | 2022-05-25 | OLO | Special | Medtronic Sofamor Danek USA, Inc. |
| K221244 | 2022-05-25 | NKB | Special | Medtronic, Inc. |
| K214010 | 2022-04-12 | MAX | Traditional | Medtronic Sofamor Danek USA, Inc. |
| K212524 | 2021-12-08 | MAX | Traditional | Medtronic Sofamor Danek USA, Inc. |
| K210425 | 2021-05-24 | MAX | Traditional | Medtronic Sofamor Danek USA, Inc. |
| K201407 | 2020-09-10 | NKB | Traditional | Medtronic Sofamor Danek USA, Inc. |
| K201362 | 2020-08-19 | PML | Traditional | Medtronic, Inc. |
| K191039 | 2019-08-26 | OLO | Traditional | Medtronic Sofamor Danek USA, Inc. |
| K173125 | 2017-12-20 | MQP | Traditional | Medtronic Sofamor Danek, Inc. |
| K172328 | 2017-11-02 | OVD | Traditional | Medtronic Sofamor Danek USA, Inc. |
| K171689 | 2017-10-05 | MAX | Traditional | Medtronic Sofamor Danek USA, Inc. |
| K170679 | 2017-05-11 | NKB | Traditional | Medtronic Sofamor Danek, Inc. |
| K162680 | 2016-12-14 | OVD | Traditional | Medtronic Sofamor Danek USA, Inc. |
| K162494 | 2016-10-04 | NKB | Special | Medtronic Sofamor Danek USA, Inc. |
| K153555 | 2016-04-07 | PGW | Traditional | Medtronic Navigation, Inc. |
| K150135 | 2015-06-11 | MAX | Traditional | Medtronic Sofamor Danek USA, Inc. |
| K143375 | 2015-02-13 | NKB | Special | Medtronic Sofamor Danek USA, Inc. |
| K141599 | 2015-01-21 | OVE | Traditional | Medtronic Sofamor Danek USA, Inc. |
| K142450 | 2014-10-01 | ODP | Special | Medtronic Sofamor Danek USA, Inc. |
| K132639 | 2013-11-25 | NKB | Traditional | Medtronic Sofamor Danek USA, Inc. |
| K123978 | 2013-04-09 | MAX | Traditional | Medtronic Sofamor Danek USA, Inc. |
| K122862 | 2012-10-03 | NKB | Special | Medtronic Sofamor Danek USA, Inc. |
| K120368 | 2012-04-09 | MAX | Traditional | Medtronic Sofamor Danek USA, Inc. |
| K112444 | 2011-11-15 | ODP | Traditional | Medtronic Sofamor Danck USA, Inc. |
| K103731 | 2011-07-18 | MAX | Traditional | Medtronic Sofamor Danek, Inc. |
| K102807 | 2010-11-17 | NKB | Special | Medtronic Sofamor Danek, Inc. |
| K094025 | 2010-04-26 | MAX | Traditional | Medtronic Sofamor Danek, Inc. |
| K091813 | 2009-11-17 | OVD | Traditional | Medtronic Sofamor Danek, Inc. |
| K083026 | 2008-12-29 | MAX | Traditional | Medtronic Sofamor Danek, Inc. |
| K073291 | 2008-04-24 | MAX | Traditional | Medtronic Sofamor Danek USA, Inc. |
| K071416 | 2007-11-01 | KWQ | Traditional | Medtronic Sofamor Danek USA, Inc. |
| K060719 | 2006-04-14 | MQP | Special | Medtronic Sofamor Danek, Inc. |
| K052747 | 2005-10-28 | NKB | Special | Medtronic Sofamor Danek, Inc. |
| K052261 | 2005-10-07 | MQP | Special | Medtronic Sofamor Danek USA, Inc. |
| K050438 | 2005-06-02 | HAW | Special | Medtronic Surgical Navigation Technologies |
| K002931 | 2000-11-24 | HRX | Traditional | Medtronic Sofamor Danek, Inc. |
| K002399 | 2000-09-27 | MNH | Special | Medtronic Sofamor Danek, Inc. |
Nearby Manufacturers
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.
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