510(k) K261189
- Device
- Freedom Nail Ankle Fusion System
- Applicant
- McGinley Orthopaedic Innovations
- 510(k) number
- K261189
- Product code
- HSB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-10-19
- Date received
- 2026-04-10
- 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
- N
Applicant Contact#
- Contact
- Adam Johnson
- Address
- 234 E. 1st St. Suite 242 Casper WY US 82601 82601
FDA Registration Numbers#
- 9617297
- 3009455196
- 3017521423
- 3008868758
- 1822565
- 3014833750
- 8043792
- 3014302784
- 3010287737
- 3015876273
- 3015877656
- 3021008900
- 3004450489
- 1835572
- 1226544
- 9614438
- 3008837339
- 3007366790
- 3008749819
- 3008514120
- 3006801265
- 3025141
- 3009381600
- 3010364775
- 3015212339
- 3007993775
- 1644408
- 3007125392
- 3013302242
- 3016727307
- 3006742481
- 2134285
- 3012392319
- 3014527928
- 3006846753
- 3000327445
- 3030412764
- 3011388423
- 3003477135
- 3015216945
- 3026593233
- 3015806723
- 3010065126
- 9613350
- 3004976965
- 3020155054
- 2953359
- 3009554293
- 3033509898
- 3008812560
- 3006017180
- 3012329552
- 1649379
- 3010057495
- 9710312
- 3010502940
- 3003761012
- 3010400367
- 3006563559
- 3010068573
- 3010106508
- 3010470577
- 3010667733
- 9615128
- 3001239363
- 9611813
- 3021336182
- 3010131578
- 2031009
- 3015869121
- 3006694268
- 3003249380
- 1833986
- 3010462278
- 3015183635
- 3010368646
- 3043543260
- 9611390
- 3010370880
- 3009732568
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 |