510(k) K202399
- Device
- OrthoButton FL
- Applicant
- Riverpoint Medical
- 510(k) number
- K202399
- Product code
- MBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-09-18
- Date received
- 2020-08-21
- Regulation
- 888.3040
- Classification name
- Fastener, Fixation, Nondegradable, Soft Tissue
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Amanda Cole
- Address
- 825 NE 25th Ave. Portland OR US 97232 97232
FDA Registration Numbers#
- 3011301313
- 1835251
- 1221934
- 3013176080
- 1417592
- 3015718210
- 3017210488
- 3008599979
- 1526711
- 3021632375
- 3044423486
- 3006460162
- 1834331
- 3010047454
- 1225492
- 3010392243
- 3038185071
- 2029275
- 3019269298
- 3026368553
- 3014560508
- 2648623
- 3010123256
- 3015075784
- 1226183
- 3016851379
- 3004365956
- 3032412536
- 3008110533
- 1048735
- 3010237768
- 3009826895
- 3003604053
- 1319660
- 1450662
- 3024856795
- 3012470322
- 2936485
- 3011061237
- 3033273526
- 3010692967
- 2032098
- 3020584246
- 3025141
- 3021393544
- 3010052483
- 3015539532
- 3007304202
- 1825034
- 3016660811
- 3015974593
- 3006742481
- 1935627
- 3006783837
- 3015216945
- 1313525
- 9681465
- 3008749819
- 3006809628
- 3010673515
- 3000270450
- 3010202439
- 3015207155
- 3009227834
- 1920664
- 1424263
- 3005941719
- 2183946
- 1219602
- 3010047402
- 3004549189
- 3035366890
- 3010273872
- 3014302784
- 3014162916
- 1643264
- 1043534
- 3003898228
- 2530154
- 3006981798
Source Documents#
Other 510(k) Records For Product Code MBI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261869 | Integrity Retractable Implant Inserter (6000127) | Anika Therapeutics, Inc. | 2026-09-17 |
| K253065 | Aevumed SUPERCYNCH™ Button System | Aevumed, Inc. | 2026-09-02 |
| K262809 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | 2026-09-02 |
| K262677 | Iconix Knotless T | Riverpoint Medical | 2026-08-27 |
| K262047 | Grappler Suture Anchor System | Paragon 28, Inc. | 2026-08-03 |
| K262369 | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down | Stryker Endoscopy | 2026-07-30 |
| K261770 | Suture Button Repair System | Skeletal Dynamics, Inc. | 2026-07-29 |
| K261632 | Thunderbolt System | Responsive Arthroscopy, Inc. | 2026-07-20 |
| K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982) | Smith & Nephew, Inc. | 2026-07-09 |
| K260018 | Arthrex FiberButton | Arthrex, Inc. | 2026-06-26 |
| K253130 | Dione PEEK Screw System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-05-27 |
| K261363 | Y-Knotless™ Flex Anchors | CONMED Corporation | 2026-05-13 |
| K253027 | Anchor with Fiber Wire and Disposable Inserter | Ortobio S.A. | 2026-05-06 |
| K252635 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | 2026-05-01 |
| K260921 | Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line | Tigon Medical | 2026-04-21 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases