510(k) K220650
- Device
- TriMed Ripcord Device
- Applicant
- TriMed, Inc.
- 510(k) number
- K220650
- Product code
- HTN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-06-01
- Date received
- 2022-03-07
- 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
- David Medoff
- Address
- 27533 Ave. Hopkins Santa Clarita CA US 91355 91355
FDA Registration Numbers#
- 3008812251
- 3014129047
- 3043620689
- 3013767421
- 3017980495
- 3015974593
- 3007109793
- 3012755988
- 3007923096
- 3010386387
- 3010622588
- 3004464325
- 3006272282
- 3010673850
- 1721676
- 3004748528
- 3015399803
- 3011989923
- 1020279
- 3008870565
- 1221934
- 1423662
- 1319639
- 3011302692
- 1835251
- 3011683674
- 1043534
- 3014004349
- 3003236702
- 1032347
- 3003541440
- 2246552
- 3006946279
- 3031261833
- 3023852420
- 3010068573
- 1835831
- 3014302784
- 3016237080
- 2183650
- 3002807310
- 3015946784
- 1424263
- 8043862
- 1051526
- 3026586698
- 2027754
- 3009812190
- 3015398319
- 2244478
- 3042765769
- 3012478585
- 3012329552
- 3005180920
- 3010049501
- 3007829657
- 3032588003
- 1835296
- 3012818475
- 3008559295
- 3014315669
- 1222274
- 3030412764
- 3030514683
- 8010944
- 3000270450
- 2032521
- 3007993775
- 3016727307
- 3009540749
- 3007738812
- 3013700547
- 3010400367
- 3008599979
- 3010120339
- 3014314623
- 3015869121
- 3014522470
- 3003761012
- 3011500362
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 |
| 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 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases