510(k) K141420
- Device
- FASTFORWARD
- Applicant
- MEDSHAPE, INC
- 510(k) number
- K141420
- Product code
- HTN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-12-18
- Date received
- 2014-05-29
- 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
- JEREMY BLAIR
- Address
- 1575 Northside Dr. Suite 440 Atlanta GA US 30318 30318
FDA Registration Numbers#
- 1000517406
- 3011061237
- 3021393544
- 3008396464
- 3031800723
- 1017294
- 3012966183
- 2133433
- 1724955
- 3002579136
- 3007738812
- 3007366790
- 3021226419
- 3011580264
- 3015398319
- 3010047454
- 3017980495
- 8031020
- 3009971621
- 3015539532
- 3007109793
- 3007829657
- 3006946279
- 3015542154
- 1319639
- 3017196117
- 3014262693
- 3013176080
- 1032347
- 3010531069
- 3014315669
- 8043734
- 3036756245
- 3004142400
- 1226544
- 3013767421
- 9613369
- 1220246
- 3010622588
- 1835251
- 3030514683
- 9611281
- 3004638532
- 1061927
- 9611813
- 3015946784
- 1043534
- 1220477
- 3005827567
- 1222928
- 3008951116
- 3015869121
- 3006498370
- 3000270450
- 2648920
- 3012478585
- 3006946276
- 2648666
- 1058584
- 2183946
- 3011500362
- 3011302692
- 3020899789
- 3010386387
- 3012818475
- 1054811
- 3020704423
- 1020279
- 3007125392
- 3015231789
- 1051526
- 3005290844
- 3014315560
- 3004369035
- 3032588003
- 3010863450
- 2032098
- 3008262872
- 3031261833
- 3004188066
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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