510(k) K113828
- Device
- DYNANAIL ANKLE ARTHRODESIS NAIL
- Applicant
- MEDSHAPE, INC
- 510(k) number
- K113828
- Product code
- HSB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-02-29
- Date received
- 2011-12-27
- Regulation
- 888.3020
- Classification name
- Rod, Fixation, Intramedullary And Accessories
- 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#
- 3003935342
- 3008812251
- 3043620689
- 3012755988
- 8030965
- 3007923096
- 3010386387
- 3043543260
- 3017521423
- 3004464325
- 3006272282
- 3004748528
- 1721676
- 3006179046
- 3005581234
- 3015399803
- 1722511
- 3018011420
- 3010364775
- 3010606097
- 1020279
- 1649379
- 3010106508
- 3010411051
- 3005061536
- 1423662
- 1835572
- 3011302692
- 3010097171
- 9610622
- 1835251
- 3011683674
- 3009141957
- 1043534
- 3014527928
- 3014004349
- 3018182995
- 3003541440
- 3006946279
- 3020155054
- 3031261833
- 3023852420
- 3010068573
- 1833920
- 1835831
- 3014302784
- 3016237080
- 1424263
- 3014967149
- 3015946784
- 3006513362
- 1051526
- 3009812190
- 3010220595
- 3012329552
- 3011127597
- 3006017180
- 2134285
- 3012724179
- 3008102042
- 3010049501
- 3004153896
- 1835296
- 3008559295
- 3014315669
- 3030412764
- 3000270450
- 3006845464
- 3007993775
- 3016727307
- 3011534620
- 3006125668
- 3009540749
- 3010400367
- 3008599979
- 3023272531
- 3014314623
- 1643817
- 3015869121
Source Documents#
Other 510(k) Records For Product Code HSB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261345 | Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2026-09-24 |
| K261481 | Pangea Femur Reconstruction System | Stryker GmbH | 2026-06-29 |
| K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) | Suzhou and Science & Technology Development Corp. | 2026-06-18 |
| K261651 | Precice™ Max System and Precice™ Ankle Salvage System | NuVasive Specialized Orthopedics | 2026-06-18 |
| K253155 | Fule Metallic Lockable Intramedullary Nail Systems | Beijing Fule Science & Technology Development Co., Ltd. | 2026-06-17 |
| K253046 | HERA Interlocking Intramedullary Nailing System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-06-16 |
| K260146 | FITBONE® TRANSPORT AND LENGTHENING SYSTEM | Orthofix Srl | 2026-05-19 |
| K253991 | Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA | Orthofix Srl | 2026-05-08 |
| K261043 | AUTOBAHN™ Nailing System | Globus Medical, Inc. | 2026-04-24 |
| K252016 | Arthrex Humeral Nails | Arthrex, Inc. | 2026-03-20 |
| K252961 | Fusion FibFix Nail | Fusion Orthopedics USA, LLC | 2026-03-18 |
| K253566 | Affixus Retrograde Femoral Nailing System | Zimmer, Inc. | 2026-03-12 |
| K253517 | Reselute Tibial Nail | Reselute, Inc. | 2026-03-10 |
| K252196 | Arthrex FibuLock Nail System | Arthrex, Inc. | 2026-03-05 |
| K253591 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2026-03-05 |
Legacy Summary#
summary
FDA Review#
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