510(k) K883361
- Device
- ARTHRO-TRAC(TM)
- Applicant
- RUDOLPH BEAVER, INC.
- 510(k) number
- K883361
- Product code
- HRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-10-13
- Date received
- 1988-08-09
- Regulation
- 888.1100
- Classification name
- Arthroscope
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- Robert Zoletti
- Address
- 411 Waverley Oaks Rd. P.O. Box 9097 Waltham MA US 02154 02154
FDA Registration Numbers#
- 1824199
- 3016851379
- 3030446844
- 2650143
- 3006546082
- 3010400367
- 3008114965
- 3001239363
- 8030607
- 3032391
- 3012322232
- 8010374
- 3021566676
- 3013944123
- 2649614
- 2953359
- 1643817
- 3003174284
- 3010273872
- 3016842760
- 1064017
- 3014262693
- 9681574
- 1834331
- 3005677016
- 3009973505
- 3021226419
- 9611112
- 9610773
- 2916714
- 3018242561
- 2183744
- 3017396949
- 3012809732
- 3001556604
- 3008494403
- 3016050940
- 3010331645
- 1056128
- 3011163668
- 1483278
- 3007993775
- 3033043422
- 3027339877
- 1320894
- 2243757
- 3005528784
- 3010202439
- 3015309643
- 9617616
- 3044156918
- 3014342096
- 3001592626
- 3005180920
- 3006946348
- 3009018440
- 3017406274
- 2084346
- 3033589330
- 1222997
- 3006849754
- 8010418
- 3008110533
- 9616662
- 3021393544
- 3009538961
- 1724474
- 2648623
- 3013517171
- 3015453963
- 3011373951
- 3030926959
- 2434839
- 3003477135
- 1649518
- 2183449
- 9615782
- 3012883081
- 1928237
- 2183911
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HRX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260203 | Fule Vertebroplasty Balloon Catheter | Beijing Fule Science & Technology Development Co., Ltd. | 2026-08-28 |
| K254103 | HOPKINS Telescopes for Arthroscopy | Karl Storz SE & CO. KG | 2026-08-26 |
| 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 |
Legacy Summary#
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FDA Review#
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