510(k) K213644
- Device
- Arthrex Knotless Mini TightRopes
- Applicant
- Arthrex Inc.
- 510(k) number
- K213644
- Product code
- HTN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-12-17
- Date received
- 2021-11-18
- Regulation
- 888.3030
- Classification name
- Washer, Bolt Nut
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Rebecca R Homan
- Address
- 1370 Creekside Blvd. Naples FL US 34108 34108
FDA Registration Numbers#
- 3014262693
- 8010944
- 2029275
- 3014129047
- 3014315669
- 3006981798
- 3022142628
- 3010041499
- 3008650117
- 3010197224
- 3014763043
- 2244478
- 3013756169
- 3009826895
- 1423662
- 3021008900
- 3010622588
- 1043653
- 3015974593
- 9611813
- 1724955
- 3013700547
- 3016851379
- 8010177
- 3007663067
- 3019269298
- 3008396464
- 3033509898
- 3010400367
- 3008110533
- 3007304202
- 3010047454
- 3017196117
- 2648920
- 3014004349
- 3032588003
- 3007993775
- 1047843
- 3015398319
- 3002907620
- 3009971621
- 2032521
- 3005874553
- 3012883081
- 3010331645
- 3010863450
- 3009996260
- 1833824
- 3008749819
- 3012755988
- 3031800723
- 3009540749
- 3009158523
- 1048735
- 3007289093
- 3008870565
- 3008868758
- 3014315560
- 3043620689
- 2532027
- 3011656326
- 3014522470
- 3012470322
- 1018470
- 3010509633
- 3008262872
- 3008951116
- 1064858
- 3010531069
- 1032347
- 3031261833
- 8043792
- 3004579081
- 1526439
- 1818910
- 3006460162
- 1220477
- 3027339877
- 3015231789
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 |
| 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 |
| K220947 | Arthrex Knotless AC Repair Devices | Arthrex, Inc. | 2022-06-06 |
Legacy Summary#
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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