510(k) K243624
- Device
- Acu-Sinch Knotless Mini
- Applicant
- Acumed, LLC
- 510(k) number
- K243624
- Product code
- HTN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-01-23
- Date received
- 2024-11-25
- 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
- Marina Bull
- Address
- 5885 NE Cornelious Pass Hillsboro OR US 97124 97124
FDA Registration Numbers#
- 3002579136
- 3016851379
- 3015806723
- 3019269298
- 3015974593
- 3004154314
- 2953359
- 3005497913
- 3007289093
- 3035373797
- 9611281
- 3044753263
- 3013700547
- 3012358417
- 3006981798
- 3043620689
- 3032588003
- 1828288
- 3010197224
- 3004464325
- 1220477
- 3006783837
- 3035366890
- 3000270450
- 3015718210
- 1724955
- 3010509633
- 3013055499
- 3006498370
- 2032098
- 1018470
- 3011302692
- 1833986
- 3021393544
- 3008812251
- 3005827567
- 3007738812
- 3010531069
- 3014262693
- 1825034
- 3016727307
- 3027242374
- 3007366790
- 3009971621
- 1048735
- 3011580264
- 3009756153
- 2027754
- 3006801265
- 3014129047
- 3008870565
- 3004638532
- 3021008900
- 3014257776
- 3012966183
- 3014314623
- 3013767421
- 3012470322
- 1221934
- 3013756169
- 3009996260
- 3021226419
- 3010060157
- 3010386387
- 8043862
- 1225838
- 3020899789
- 3007441485
- 1051526
- 3007829657
- 8043734
- 1423662
- 3011656326
- 3006001176
- 1222274
- 3014967969
- 3009826895
- 1043534
- 3016261131
- 1720929
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 |
| 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 |