510(k) K253115
- Device
- LARS ACJ
- Applicant
- Movmedix S.A.S.
- 510(k) number
- K253115
- Product code
- HTN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-10
- Date received
- 2025-09-24
- Regulation
- 888.3030
- Classification name
- Washer, Bolt Nut
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Luisa Arcos
- Address
- 5 Rue De La Fontaine Arc-Sur-Tille FR 21560 21560
FDA Registration Numbers#
- 3014302784
- 3013767421
- 3010060157
- 3015882686
- 3001239363
- 3004638532
- 3006001176
- 1424263
- 3014273501
- 3003761012
- 1043534
- 3035366890
- 3007420745
- 3012470322
- 1935627
- 2183650
- 3008396464
- 1825034
- 3008749819
- 3015806723
- 3012818475
- 3021393544
- 3015207155
- 3009971621
- 3011302692
- 3007663067
- 3005180920
- 3003236702
- 3007109793
- 3011061237
- 2090040
- 3016237080
- 3016261131
- 3025141
- 1054811
- 1058584
- 9616944
- 3038503932
- 2532027
- 1724955
- 1017294
- 3035373797
- 3007319107
- 3003139373
- 1043653
- 3004188066
- 3014004349
- 2183946
- 3008812251
- 1835296
- 3032412536
- 3003755939
- 3012478585
- 1649390
- 3010197224
- 1220246
- 3013011598
- 3017196117
- 3008559295
- 3003525643
- 3009631939
- 3013176080
- 3004748528
- 3008868758
- 2032098
- 3013756169
- 3003604053
- 3026586698
- 3011656326
- 3006498370
- 3002949614
- 3015542154
- 1833506
- 3027339877
- 3025603301
- 3044753263
- 9613369
- 1319639
- 2246552
- 1032347
Source Documents#
Other 510(k) Records For Product Code HTN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252081 | SportLinc Syndesmosis Device | Lincotek Medical | 2026-03-27 |
| K253727 | Syndesmosis TightRope PRO | Arthrex, Inc. | 2025-12-22 |
| K251643 | Synchfix EVT | Wright Medical Technology, Inc. (Stryker Corporation) | 2025-10-29 |
| K251134 | RipCord | TriMed, Inc. | 2025-07-11 |
| K243624 | Acu-Sinch Knotless Mini | Acumed, LLC | 2025-01-23 |
| K242091 | Bolo Button System | Fusion Orthopedics | 2024-12-23 |
| K243408 | TACTIX Vector Syndesmosis System | Vilex, LLC | 2024-11-27 |
| K242311 | EXPERT - Flexible Joint Fixation System | GM Dos Reis Industria e Comercio Ltda. | 2024-11-01 |
| K240035 | TACTIX Vector Syndesmosis System | Vilex, LLC | 2024-08-01 |
| K240947 | TENSOR® Suture Button System | Globus Medical, Inc. | 2024-06-03 |
| K233531 | OIC FLEX-FIX™ System | Orthopaedic Implant Company | 2024-02-02 |
| K232780 | CC-Clip® Implant System | Cc-Instruments, Inc. | 2023-12-18 |
| K232755 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. | 2023-10-06 |
| K221485 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. | 2022-08-22 |
| K220947 | Arthrex Knotless AC Repair Devices | Arthrex, Inc. | 2022-06-06 |