510(k) K190582
- Device
- MicroLink All-Suture Button Fixation System (Radiopaque)
- Applicant
- CONMED Corporation
- 510(k) number
- K190582
- Product code
- HTN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-06-28
- Date received
- 2019-03-06
- 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
- Diana L. Nader-Martone
- Address
- 525 French Rd. Utica NY US 13502 13502
FDA Registration Numbers#
- 1835251
- 1221934
- 3013176080
- 1417592
- 3008951116
- 3015718210
- 3008599979
- 3001239363
- 3006460162
- 3026586698
- 3010047454
- 2029275
- 3005290844
- 3019269298
- 2133433
- 1835831
- 3010386387
- 3004635447
- 3010123256
- 3004748528
- 3014257776
- 3014315669
- 3016851379
- 3042765769
- 3032412536
- 3008110533
- 3032588003
- 1048735
- 3010237768
- 3009826895
- 3003604053
- 1450662
- 3012470322
- 3011061237
- 3017980495
- 3031261833
- 1526439
- 3016537375
- 1833986
- 2032098
- 3005827567
- 3009158523
- 3010509633
- 3025141
- 3009996260
- 3007125392
- 3021393544
- 3015539532
- 3007829657
- 3007304202
- 1825034
- 3035373797
- 3015974593
- 1935627
- 3006783837
- 3009756153
- 1000517406
- 3016261131
- 3008749819
- 3000270450
- 3015207155
- 2027754
- 3008812251
- 3004638532
- 1424263
- 3035366890
- 2183946
- 1219602
- 3012478585
- 3010273872
- 3014302784
- 1643264
- 3010673850
- 1043534
- 3006981798
- 3009540749
- 1064129
- 3011656326
- 3006001176
- 3012818475
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