510(k) K180876
- Device
- DTRAX Spinal System
- Applicant
- Providence Medical Technology, Inc.
- 510(k) number
- K180876
- Product code
- HRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-05-18
- Date received
- 2018-04-03
- Regulation
- 888.1100
- Classification name
- Arthroscope
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Edward Liou
- Address
- 3857 Hopyard Rd., Suite 300 Pleasanton CA US 94588 94588
FDA Registration Numbers#
- 3021477808
- 3015806723
- 1526534
- 9680721
- 3010264076
- 3007024186
- 2183449
- 3010419931
- 3008058135
- 3010202439
- 3006849754
- 3007305485
- 9611112
- 3014579161
- 3008114965
- 9610617
- 3014262693
- 3016851379
- 3014202166
- 3011944170
- 1221826
- 3009704301
- 3009328501
- 3007955117
- 3017196117
- 9615896
- 9680340
- 3030926959
- 3009702671
- 1721504
- 3043226252
- 3012790575
- 3023155873
- 3010432890
- 3008125983
- 3002907620
- 1064017
- 1721686
- 9681574
- 3004142400
- 1123169
- 2020601
- 1055236
- 3015539532
- 1650907
- 3010120148
- 3032391
- 3010132111
- 1030489
- 3017565094
- 9615001
- 3002579136
- 1423625
- 3014232239
- 3012494290
- 2523676
- 3027339877
- 9617601
- 3017406274
- 1048735
- 9617070
- 1226424
- 3001592626
- 3006498370
- 3006546082
- 3007738736
- 1834331
- 3009394448
- 3036756245
- 3008110533
- 3005382983
- 3008573567
- 3003704957
- 3021393544
- 2650143
- 3005083075
- 3000270450
- 3008583793
- 3007113251
- 3004920696
Source Documents#
Other 510(k) Records For Product Code HRX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252790 | Digital ClarusScope System and Digital NeuroPEN System | Clarus Medical, LLC | 2026-05-26 |
| K253523 | Freedom DS™ Decompression System | Spinal Simplicity | 2026-04-16 |
| K252546 | VantageTM Lumbar Decompression Kit | Allevion Medical, LLC | 2026-03-12 |
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) | Medimaging Integrated Solution, Inc (Miis) | 2025-12-23 |
| K250795 | PUREVUE™ FMS | W.O.M. World of Medicine GmbH | 2025-12-05 |
| K252666 | Articulator Arthroscopic Bur | Joint Preservation Innovations, LLC | 2025-11-21 |
| K252458 | Kyphoplasty Balloon Dilatation Catheters | Shanghai Lange Medtech Co., Ltd. | 2025-11-03 |
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly | Hand Biomechanics Lab, Inc. | 2025-10-15 |
| K252594 | UltraGuideCTR® image guided soft tissue release system | Sonex Health | 2025-09-29 |
| K243774 | ELID (Endoscopic Less Invasive Decompression) System | Lesspine Innovations | 2025-08-27 |
| K241990 | SpineSite Endoscope System | Hydrocision, Inc. | 2025-07-30 |
| K243602 | Arthrex Spine Endoscope | Arthrex, Inc. | 2025-05-16 |
| K242417 | VECTR – Video Endoscopic Carpal Tunnel Release System | Rafael Medical Devices, LLC | 2024-12-11 |
| K243020 | MIDASVu | Intravu, Inc. | 2024-12-02 |
| K233800 | Vertos mild Device Kit (MDK-0002) | Vertos Medical, Inc. | 2024-05-06 |
Legacy Summary#
summary
FDA Review#
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