510(k) K896196
- Device
- ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAR
- Applicant
- ORTHOCONCEPT, INC.
- 510(k) number
- K896196
- Product code
- HRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-12-01
- Date received
- 1989-10-25
- 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
- JACK DEFRANCO
- Address
- 8 Cold Branch Ct. Columbia SC US 29223 29223
FDA Registration Numbers#
- 1221934
- 3013176080
- 3003678543
- 3003902757
- 3006849754
- 2029275
- 3004111573
- 3006787036
- 3012447612
- 2648623
- 3012322232
- 3018242561
- 1836161
- 3009538961
- 2032098
- 3009499159
- 3012790575
- 2434839
- 3007955117
- 8030607
- 3014479313
- 3013944123
- 3044858680
- 3012818475
- 3015542154
- 1526611
- 3009417901
- 3012358417
- 3035858921
- 1061124
- 3009475067
- 1064017
- 2919128
- 1320894
- 3030153385
- 2020601
- 1055236
- 3016789487
- 1221826
- 1222997
- 3020704423
- 3032391
- 3025318945
- 3016112537
- 1045254
- 3009394448
- 3013557562
- 9611102
- 3009018440
- 2032677
- 3013404959
- 3000286616
- 2183744
- 8010349
- 3015453963
- 3002806603
- 1423662
- 9611665
- 2531321
- 3014200871
- 3044156918
- 3011373951
- 3014615697
- 3010155661
- 3030447506
- 1018470
- 3007421149
- 3009973505
- 3015399803
- 3024021261
- 2245304
- 2953359
- 3015806723
- 3025603301
- 3007738736
- 1721686
- 8040510
- 3013517171
- 3004194523
- 3012329552
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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