510(k) K240947
- Device
- TENSOR® Suture Button System
- Applicant
- Globus Medical, Inc.
- 510(k) number
- K240947
- Product code
- HTN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-06-03
- Date received
- 2024-04-08
- 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
- Jennifer Antonacci
- Address
- Valley Forge Business Center 2560 General Armistead Ave. Audubon PA US 19403 19403
FDA Registration Numbers#
- 3043620689
- 3002949614
- 2031009
- 1221934
- 3013700547
- 3017980495
- 3015718210
- 3004369035
- 1835831
- 9680619
- 3010331645
- 1032347
- 3007738812
- 3015806723
- 2031093
- 3014522470
- 3006783837
- 8010944
- 1526534
- 1818910
- 2090040
- 3016237080
- 3003541440
- 1000517406
- 3010197224
- 3014314623
- 3027242374
- 3015399803
- 3035373797
- 3010622588
- 3007109793
- 1721676
- 1720929
- 1424263
- 1527105
- 8043734
- 3015974593
- 3004748528
- 3003477135
- 3010120339
- 3010531069
- 3009973336
- 9611813
- 1833986
- 2648920
- 3012358417
- 1222274
- 3009996260
- 3004635447
- 3010509633
- 1220246
- 3033509898
- 1822565
- 3021336182
- 3013365802
- 3020899789
- 2532027
- 3006946276
- 3006272282
- 3009812190
- 1222928
- 1825034
- 3008114965
- 3010155648
- 3030514683
- 3006001176
- 3014262693
- 3007420745
- 3032412536
- 2027754
- 3016851379
- 3010863450
- 3005827567
- 3010049501
- 3007923096
- 1054811
- 3035366890
- 2183744
- 3011061237
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 |
| 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 |
| K220650 | TriMed Ripcord Device | TriMed, Inc. | 2022-06-01 |