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#
- 3019807891
- 3010863450
- 3010237768
- 3017980495
- 3003541440
- 3004188066
- 1526534
- 2027754
- 3013767421
- 2032521
- 3012329552
- 3012755988
- 1720929
- 9611281
- 1043534
- 1319639
- 3002807315
- 3014763043
- 3012358417
- 3004154314
- 3008951116
- 3027242374
- 3030514683
- 1835296
- 3003477135
- 3008650117
- 3011580264
- 2532027
- 8020712
- 3015869121
- 8010944
- 3008749819
- 3014257776
- 3007304202
- 9613350
- 8031020
- 8010177
- 3003236702
- 3042765769
- 1822565
- 3008599979
- 3015806723
- 3008110533
- 3006801265
- 1527105
- 3010400367
- 1222928
- 3013176080
- 3006946276
- 3011683674
- 3014129047
- 1835251
- 3005497913
- 3014315669
- 3009756153
- 3008396464
- 1054811
- 3005827567
- 3031261833
- 3005874553
- 3007366790
- 3011500362
- 1526439
- 1017294
- 3015869493
- 1721676
- 3012818475
- 3006001176
- 3009417901
- 1649518
- 1424263
- 3010386387
- 3013365802
- 3015398319
- 3031800723
- 3004635447
- 1643264
- 3026586698
- 1064858
- 2031009
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 |
| 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 |