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Sign in to claim this brandMedtronic Powered Surgical Solutions
United States·US-MF-000023270
Last updated September 17, 2026
What Medtronic Powered Surgical Solutions makes
The company manufactures single-use orthopaedic burs and reusable surgical cleaning utensils, alongside pneumatic and electric surgical power tool motors, foot-switches, and control units for line-powered and pneumatic systems. Their portfolio also includes burring power tool attachments and pneumatic surgical power tool hoses, designed for orthopaedic procedures.
These devices are classified under Class I and Class II in the FDA’s UDI system and are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Medtronic Powered Surgical Solutions manufacture?
Medtronic Powered Surgical Solutions specializes in surgical power tools and accessories primarily for orthopaedic procedures. Their portfolio includes single-use orthopaedic burs, pneumatic and electric surgical power tool motors, foot-switches, control units (both pneumatic and line-powered), burring power tool attachments, pneumatic surgical hoses, and reusable surgical cleaning utensils. These devices are designed to assist in bone and joint surgeries.
Where is Medtronic Powered Surgical Solutions based?
The company is headquartered in the United States. While the exact location isn’t specified, the U.S. is the primary country of operation for their medical device manufacturing and distribution.
Which regulatory registries list the devices made by Medtronic Powered Surgical Solutions?
The devices produced by Medtronic Powered Surgical Solutions are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for medical devices authorized in the U.S. under the FDA’s regulatory framework.
How are the devices manufactured by Medtronic Powered Surgical Solutions classified under FDA regulations?
The devices fall under Class I and Class II classifications in the FDA’s UDI system. Class I generally includes low-risk devices requiring general controls, while Class II involves additional performance standards or special controls due to moderate risk. The classification depends on factors like intended use, risk level, and design complexity, as outlined in FDA guidelines.
Are the devices from Medtronic Powered Surgical Solutions reusable or single-use?
The company manufactures both single-use and reusable devices. Most notably, they produce single-use orthopaedic burs, while their reusable offerings include surgical cleaning utensils and certain power tool components. The distinction is important for infection control and regulatory compliance, as single-use devices are designed for one-time use to minimize cross-contamination risks.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 4620 , North Beach Street, Forth Worth, United States
- Website
- medtronic.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- David Breiter
- EUDAMED SRN
- US-MF-000023270
- FDA FEI Number
- 1625507
- DUNS Number
- —
Catalogue (4170)
Page 5 of 84| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Midas Rex | ES300-R | FDA UDI | Class II | Active |
| Midas Rex MR8 | MR8-10BA20DFL | FDA UDI | Class II | Active |
| Midas Rex | 9BA40T | FDA UDI | Class II | Active |
| Midas Rex® | EF201 | FDA UDI | Class II | Active |
| Midas Rex Mr8 | MR8-14BA30SH | FDA UDI | Class II | Active |
| Midas Rex ™ | 180S55-04F | FDA UDI | Class II | Active |
| Midas Rex | AS14-R | FDA UDI | Class II | Active |
| Midas Rex MR8 | MR8-26CY90 | FDA UDI | Class I | Active |
| Midas Rex Legend | 21BA70DX | FDA UDI | Class II | Active |
| Midas Rex Legend | 7BA40 | FDA UDI | Class II | Active |
| Midas Rex Mr8 | MR8-14CY76L | FDA UDI | Class II | Active |
| Midas Rex Legend | T12MH20 | FDA UDI | Class II | Active |
| Midas Rex MR8 | MR8-SD12MH30 | FDA UDI | Class II | Active |
| Midas Rex Legend | 10MH22D | FDA UDI | Class II | Active |
| Midas Rex MR8 | MR8-9BA30T | FDA UDI | Class II | Active |
| Midas Rex Legend | 8TD126 | FDA UDI | Class II | Active |
| Midas Rex Mr8 | MR8-AF01 | FDA UDI | Class II | Active |
| Midas Rex Mr8 | MR8-7BA40F | FDA UDI | Class II | Active |
| Midas Rex | 9OV55 | FDA UDI | Class II | Active |
| Midas Rex ™ | 14BA50DCSH | FDA UDI | Class II | Active |
| Midas Rex ™ | 14MH30DM15 | FDA UDI | Class II | Active |
| Triton® | ED500 | FDA UDI | Class II | Active |
| Midas Rex™ | ASJL | FDA UDI | Class II | Active |
| Midas Rex Mr8 | MR8-14CY50L | FDA UDI | Class II | Active |
| Ent Mr8 | 1847B20SDM | FDA UDI | Class II | Active |
| Midas Rex ™ | 75BA35LF | FDA UDI | Class II | Active |
| Midas Rex ™ | 14CY90 | FDA UDI | Class II | Active |
| Midas Rex Legend | T9MH25D | FDA UDI | Class II | Active |
| Midas Rex | AVA14DK-R | FDA UDI | Class II | Active |
| Midas Rex ™ | 14MH30L | FDA UDI | Class II | Active |
| Midas Rex ™ | 15CY30DCD | FDA UDI | Class II | Active |
| Midas Rex MR8 | MR8-LP05BA20DC | FDA UDI | Class II | Active |
| Midas Rex Legend | 10BA10DL-MN | FDA UDI | Class II | Active |
| Midas Rex ™ | 8TD106 | FDA UDI | Class II | Active |
| Midas Rex Mr8 | MR8-T12MH15 | FDA UDI | Class II | Active |
| Midas Rex Mr8 | MR8-SP12MH25D | FDA UDI | Class I | Active |
| Midas Rex Legend | 8TA11 | FDA UDI | Class II | Active |
| Midas Rex ™ | 15BA60D | FDA UDI | Class II | Active |
| Midas Rex Mr8 | MR8-10MH30 | FDA UDI | Class II | Active |
| Midas Rex Mr8 | MR8-7BA50F | FDA UDI | Class II | Active |
| Midas Rex™ | PM710 | FDA UDI | Class II | Active |
| Midas Rex MR8 | MR8-7BA30DXFL | FDA UDI | Class II | Active |
| Midas Rex ™ | 7TD1117 | FDA UDI | Class II | Active |
| Midas Rex Legend | 15BA50T | FDA UDI | Class II | Active |
| Mids Rex Mr8 | MR8-10BA30 | FDA UDI | Class II | Active |
| Midas Rex Mr8 | MR8-18MH30D | FDA UDI | Class II | Active |
| Midas Rex® | PA700 | FDA UDI | Class II | Active |
| Midas Rex MR8 | MR8-21BA90 | FDA UDI | Class II | Active |
| Midas Rex Legend | 26BA70DX | FDA UDI | Class II | Active |
| Midas Rex™ | 10BA30SH | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
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Authorities
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Medtronic Powered Surgical Solutions has two recall records initiated between June 29, 2005, and May 30, 2008, both of which are marked as terminated. The first involved complaints of a finger control component detaching and entering an open surgical wound, while the second concerned cutting flute geometry on surgical dissecting tools potentially exceeding tolerance limits, which may affect cutting performance, overheating, or require surgical revision.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| May 30, 2008 | Z-2156-2008 | — | terminated | Cutting flute geometry of surgical dissecting tools may be outside of established tolerance. This may lead to reduced cutting performance, inability to perform desired dissection, increased risk of overheating, and potential need for revision surgery. |
| Jun 29, 2005 | Z-1067-05 | — | terminated | Complaints of finger control component breaking off and falling into open surgical wound. |