510(k) K251643
- Device
- Synchfix EVT
- Applicant
- Wright Medical Technology, Inc. (Stryker Corporation)
- 510(k) number
- K251643
- Product code
- HTN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-10-29
- Date received
- 2025-05-29
- 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
- Rachel Warnock
- Address
- 1023 Cherry Rd. Memphis TN US 38117 38117
FDA Registration Numbers#
- 3002949614
- 3011302692
- 3004748528
- 3007304202
- 8044102
- 3010068573
- 3014004349
- 1222928
- 3014522470
- 3025141
- 1219602
- 3030412764
- 3003761012
- 3020899789
- 2031009
- 3011230048
- 2648920
- 3003541440
- 3003477135
- 1020279
- 3004369035
- 3009973699
- 3009756153
- 3008868758
- 3016537375
- 3010120339
- 1225838
- 1833824
- 3007420745
- 3042765769
- 3010060157
- 3008870565
- 3015453963
- 3010155648
- 1226544
- 1054811
- 1064129
- 3013011598
- 3014315669
- 3014257776
- 3014315560
- 2030624
- 3014967969
- 8043734
- 2027754
- 3027339877
- 3007319107
- 3009971621
- 3010123256
- 1221934
- 1064858
- 2648666
- 1000517406
- 3006783837
- 3009973336
- 3007993775
- 3010049501
- 3014302784
- 1527105
- 3008749819
- 1822565
- 3007289093
- 8031020
- 2183744
- 3016237080
- 2532027
- 8043792
- 3013680140
- 1032347
- 3032588003
- 3004142400
- 3016851379
- 2032521
- 3009812190
- 3003604053
- 1724955
- 3009631939
- 1450662
- 1226146
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 |
| 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 |
| K220650 | TriMed Ripcord Device | TriMed, Inc. | 2022-06-01 |