510(k) K251134
- Device
- RipCord
- Applicant
- TriMed, Inc.
- 510(k) number
- K251134
- Product code
- HTN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-07-11
- Date received
- 2025-04-11
- 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
- Divya Raghavi Nandakumar
- Address
- 27533 Ave. Hopkins Santa Clarita CA US 91355 91355
FDA Registration Numbers#
- 3003236702
- 3031240334
- 1226146
- 3007289093
- 3013011598
- 3009158523
- 1526439
- 1649518
- 3020899789
- 3009540749
- 3002579136
- 9680619
- 1320894
- 3011500362
- 3007109793
- 3021336182
- 3014302784
- 3032588003
- 2027754
- 9611281
- 3027339877
- 1226544
- 8020712
- 3001239363
- 3014257776
- 1043534
- 9611813
- 3004635447
- 3033509898
- 3025603301
- 1319639
- 3004748528
- 3010400367
- 3011580264
- 3005497913
- 3013700547
- 1828288
- 3034676720
- 3010331645
- 3007441485
- 3009756153
- 1064129
- 1721676
- 1526534
- 3012755988
- 1219602
- 3002949614
- 2032521
- 2183744
- 3005874553
- 1222274
- 3027242374
- 2031093
- 1225838
- 3004638532
- 8010177
- 3006981798
- 2031009
- 1833986
- 2953359
- 3019269298
- 2648920
- 3011296511
- 3020704423
- 3021393544
- 3009973336
- 1220246
- 3006946276
- 3014262693
- 3003525643
- 3015399803
- 1720929
- 3015542154
- 3006946279
- 3015539532
- 3014522470
- 1835296
- 3007738812
- 3013365802
- 3008599979
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 |
| 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 |