510(k) K240035
- Device
- TACTIX Vector Syndesmosis System
- Applicant
- Vilex, LLC
- 510(k) number
- K240035
- Product code
- HTN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-08-01
- Date received
- 2024-01-04
- 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
- No
Applicant Contact#
- Contact
- Brock Johnson
- Address
- 111 Moffitt St. Mcminnville TN US 37110 37110
FDA Registration Numbers#
- 3043620689
- 3009996260
- 9680619
- 3014315560
- 3005497913
- 3010155648
- 1721676
- 3011500362
- 3027339877
- 3004635447
- 3042765769
- 3006946276
- 3010047454
- 1226544
- 1833986
- 1220246
- 3034676720
- 3004188066
- 1320894
- 3010673850
- 3010667733
- 3006498370
- 3007829657
- 3005290844
- 3011230048
- 3003761012
- 3006783837
- 3015398319
- 3010120339
- 3012478585
- 3020704423
- 1221934
- 3003236702
- 3022142628
- 3008559295
- 3021226419
- 3009973336
- 3012329552
- 3003477135
- 3014302784
- 3025603301
- 3009158523
- 3012883081
- 3008262872
- 3027242374
- 3010197224
- 1527105
- 9613369
- 3016084569
- 3009423112
- 1526534
- 3010400367
- 1043534
- 3020899789
- 1649518
- 3014763043
- 3044753263
- 1032347
- 3016537375
- 3014315669
- 3015946784
- 3007738812
- 3009971621
- 3021393544
- 1833824
- 1225838
- 3013055499
- 3031800723
- 3007319107
- 3014522470
- 3008599979
- 3015869121
- 3010068573
- 3014273501
- 1047843
- 3004464325
- 3013767421
- 3038503932
- 1222274
- 3010386387
Source Documents#
Other 510(k) Records For Product Code HTN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253115 | LARS ACJ | Movmedix S.A.S. | 2026-06-10 |
| 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 |
| 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 |