510(k) K162996
- Device
- INVISIKNOT Ankle Syndesmosis Repair Kit
- Applicant
- SMITH & NEPHEW, INC.
- 510(k) number
- K162996
- Product code
- HTN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-06-08
- Date received
- 2016-10-27
- 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
- GREGORY NEAL
- Address
- 150 Minuteman Rd. Andover MA US 01810 01810
FDA Registration Numbers#
- 3015869493
- 3003755939
- 3010673850
- 3015231789
- 9612277
- 1000517406
- 2532027
- 3025141
- 3004188066
- 3008870565
- 3013011598
- 3021336182
- 3012883081
- 2648920
- 1048735
- 1835296
- 3014967969
- 3007663067
- 3015882686
- 1047843
- 2648666
- 1226544
- 3035366890
- 3012966183
- 3004579081
- 3009417901
- 3003541440
- 9613369
- 3010123256
- 3008868758
- 1064129
- 1017294
- 3031240334
- 3009973336
- 3005874553
- 3007923096
- 1643264
- 3003525643
- 3010386387
- 3003139373
- 1649518
- 3013680140
- 3007289093
- 2031093
- 3016084569
- 1319639
- 1721676
- 8043734
- 1833506
- 1818910
- 3000270450
- 3038503932
- 2246552
- 3010041499
- 3027242374
- 3010060157
- 3008114965
- 1054811
- 3007366790
- 3014262693
- 3042765769
- 1828288
- 3006498370
- 3022142628
- 3016237080
- 1724955
- 1018470
- 3008951116
- 3017196117
- 3044753263
- 3014004349
- 1649390
- 3009540749
- 3002807315
- 3009423112
- 3010509633
- 2133433
- 3004748528
- 1835251
- 3012329552
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#
summary
FDA Review#
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