510(k) K953434
- Device
- MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS)
- Applicant
- MIDAS REX PNEUMATIC TOOLS, INC.
- 510(k) number
- K953434
- Product code
- HBB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-05-16
- Date received
- 1995-07-21
- Regulation
- 882.4370
- Classification name
- Motor, Drill, Pneumatic
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD A HAMER
- Address
- 100 E. 15th St.,Suite 320 Fort Worth TX US 76102 76102
FDA Registration Numbers#
- 3040335671
- 3036756245
- 3015967359
- 3003120897
- 3004464325
- 3010173425
- 9616696
- 3017210488
- 3014479313
- 1058584
- 9610612
- 3008812560
- 2916714
- 3002807310
- 3001239363
- 1045834
- 1834331
- 8030965
- 3000270450
- 1030489
- 1000200989
- 3009417901
- 3005382983
- 2647346
- 1625507
- 3010155648
- 2648623
- 3033509898
- 3021632375
- 3007031059
- 3015453963
- 3025603301
- 3007997036
- 3004598644
- 3018094310
- 3003595343
- 1649518
- 1723170
- 1828288
- 1048735
- 3016172274
- 1045254
- 3008868758
- 1061124
- 1017294
Source Documents#
Other 510(k) Records For Product Code HBB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253772 | Velocity Alpha MR High Speed Surgical Drill System | Adeor Medical AG | 2026-03-06 |
| K172907 | ELAN 4 Air Motor System | Aesculap, Inc. | 2018-11-09 |
| K163182 | Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories | Medtronic Powered Surgical Solutions | 2017-03-23 |
| K150801 | Stryker Maestro Air Motors | Stryker Corporation | 2015-05-22 |
| K101168 | LEGEND POWER ADAPTER MODEL: 6475000 | Medtronic Sofamor Danek | 2010-08-24 |
| K093361 | SYNTHES AIR PEN DRIVE (APD) SYSTEM | Synthes (Usa) | 2010-04-14 |
| K090112 | MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700 | Medtronic Powered Surgical Solutions | 2009-03-26 |
| K061297 | ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM | The Anspach Effort, Inc. | 2007-01-26 |
| K061725 | STRYKER ARIA PNEUMATIC SYSTEM | Stryker Instruments | 2006-10-26 |
| K042974 | MEDICON VIPAIR HIGH SPEED SYSTEM | Medicon EG | 2005-01-13 |
| K041754 | STRYKER MAESTRO SYSTEM | Stryker Corp. | 2004-09-07 |
| K040186 | ANSPACH MRI SAFE SURGICAL DRILL SYSTEM | The Anspach Effort, Inc. | 2004-04-15 |
| K023066 | DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC) | Sodemsystems | 2002-11-25 |
| K020069 | MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM | Medtronic Midas Rex | 2002-03-18 |
| K013091 | ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM | Von Zeppelin GmbH | 2002-01-25 |
Legacy Summary#
summary
FDA Review#
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