510(k) K252144
- Device
- Iconix Speed Anchor; Iconix Speed HA+ Anchor
- Applicant
- Riverpoint Medical
- 510(k) number
- K252144
- Product code
- MBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-07-30
- Date received
- 2025-07-08
- 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
- N
Related Records
Applicant Contact
- Contact
- Bianca Silva de Sousa
- Address
- 825 NE 25th Ave. Portland OR US 97232 97232
FDA Registration Numbers
- 3013111980
- 1423662
- 1450662
- 3014967969
- 3005180920
- 3006498370
- 3021226419
- 3030926959
- 3009540749
- 3010692967
- 1649390
- 3015131017
- 2650143
- 3013176080
- 3032412536
- 3021008900
- 1043534
- 3016727307
- 3010060157
- 3027454646
- 2031917
- 3015453963
- 2183744
- 3013404959
- 3004579081
- 8044102
- 3006108336
- 2183946
- 2320767
- 1834331
- 3013756169
- 3015075784
- 2032098
- 1018470
- 3000203391
- 3009513193
- 3007420745
- 3014560508
- 3006809628
- 3002579136
- 3015806723
- 2648666
- 3011301313
- 3012818475
- 1313525
- 2649614
- 2031093
- 3010163695
- 3004142400
- 1643264
- 3007193505
- 1043653
- 3010202439
- 2246552
- 3014763043
- 1319660
- 3006460162
- 1721676
- 3015718210
- 3026368553
- 3007593722
- 3010162973
- 1226183
- 3004976965
- 3010303097
- 3025608439
- 3027339877
- 3017210488
- 3011580264
- 3017196117
- 3043620689
- 3013767421
- 1222274
- 3009756327
- 3010237768
- 3014680795
- 3013302242
- 3009423112
- 3003139373
Source Documents
Other 510(k) Records For Product Code MBI
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| K254306 | Aevumed FENIX Suture Anchor | Aevumed, Inc. | 2026-03-04 |
| K254229 | Arthrex Nano FiberTak Suture Anchor | Arthrex, Inc. | 2026-03-02 |
| K253695 | LigaMend | Riverpoint Medical, LLC | 2026-02-27 |
| K253763 | Y-KnotlessĀ Flex Anchors | Conmed Corporation | 2026-01-29 |