Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories
FDA 510(k) clearance K163182 · decided 2017-03-23
Clearance details
- K-number
- K163182
- Device name
- Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories
- Applicant
- Medtronic Powered Surgical Solutions
- Decision
- Substantially Equivalent
- Date received
- 2016-11-14
- Decision date
- 2017-03-23
- Days to decision
- 129 days
- Clearance type
- Traditional
- Product code
- HBB
- Device class
- 2
- Regulation number
- 882.4370
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Velocity Alpha MR High Speed Surgical Drill System (K253772) | Adeor Medical AG | 2026-03-06 |
| ELAN 4 Air Motor System (K172907) | Aesculap, Inc. | 2018-11-09 |
| Stryker Maestro Air Motors (K150801) | Stryker Corporation | 2015-05-22 |
| LEGEND POWER ADAPTER MODEL: 6475000 (K101168) | Medtronic Sofamor Danek | 2010-08-24 |
| SYNTHES AIR PEN DRIVE (APD) SYSTEM (K093361) | Synthes (Usa) | 2010-04-14 |
| MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700 (K090112) | Medtronic Powered Surgical Solutions | 2009-03-26 |
| ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM (K061297) | The Anspach Effort, Inc. | 2007-01-26 |
| STRYKER ARIA PNEUMATIC SYSTEM (K061725) | Stryker Instruments | 2006-10-26 |
| MEDICON VIPAIR HIGH SPEED SYSTEM (K042974) | Medicon EG | 2005-01-13 |
| STRYKER MAESTRO SYSTEM (K041754) | Stryker Corp. | 2004-09-07 |
| ANSPACH MRI SAFE SURGICAL DRILL SYSTEM (K040186) | The Anspach Effort, Inc. | 2004-04-15 |
| DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC) (K023066) | Sodemsystems | 2002-11-25 |
Recalls involving this device
No recalls on record reference this clearance.