510(k) K220947
- Device
- Arthrex Knotless AC Repair Devices
- Applicant
- Arthrex, Inc.
- 510(k) number
- K220947
- Product code
- HTN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-06-06
- Date received
- 2022-04-01
- 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
- Ivette Galmez
- Address
- 1370 Creekside Blvd. Naples FL US 34108 34108
FDA Registration Numbers#
- 3021393544
- 3004369035
- 1935627
- 2532027
- 3010047454
- 3015869121
- 1032347
- 3004464325
- 3010068573
- 1833506
- 3012883081
- 3035373797
- 1319639
- 1226544
- 3003236702
- 3004188066
- 3008812560
- 1220477
- 3032588003
- 3009158523
- 3016237080
- 1221934
- 3014314623
- 1043534
- 3010331645
- 3021226419
- 3007993775
- 3027339877
- 2953359
- 3026586698
- 3012358417
- 1527105
- 3006801265
- 3005497913
- 9680619
- 3010386387
- 3008749819
- 3010622588
- 3019269298
- 3010509633
- 2648920
- 3014262693
- 3004579081
- 3003604053
- 3013700547
- 2090040
- 1818910
- 3005180920
- 2183946
- 3027242374
- 3002949614
- 3013055499
- 3010197224
- 1417592
- 2246552
- 1051526
- 3015882686
- 3007420745
- 3008599979
- 3010123256
- 1018470
- 3009826895
- 3011061237
- 2031093
- 3011656326
- 3016537375
- 3007829657
- 9613350
- 3011296511
- 3011302692
- 3009973336
- 9612277
- 3015542154
- 3012755988
- 3007109793
- 3022142628
- 1526439
- 3008110533
- 9616944
- 3001239363
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 |