510(k) K182170
- Device
- PRECICE® BONE TRANSPORT™ System
- Applicant
- NuVasive Specialized Orthopedics, Inc.
- 510(k) number
- K182170
- Product code
- HSB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-02-05
- Date received
- 2018-08-10
- 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
- No
Applicant Contact#
- Contact
- Vidhi Bhatt
- Address
- 101 Enterprise, Suite 100 Alisa Viejo CA US 92656 92656
FDA Registration Numbers#
- 3010667733
- 3014314623
- 3010287665
- 3008837339
- 2183946
- 1720929
- 9710312
- 3034676720
- 3006272282
- 3005497913
- 3010440433
- 3025603301
- 3007993775
- 3016237080
- 3008812251
- 2022435
- 3009996260
- 3012724179
- 1043534
- 1220477
- 3014976005
- 3014004349
- 3010220595
- 3009732568
- 1220246
- 3021008900
- 3011500362
- 3014273424
- 3015806723
- 3004983210
- 1833506
- 1424434
- 3009381600
- 3000327445
- 3006001176
- 1644408
- 1835296
- 3012329552
- 3009812190
- 3010400367
- 3009998573
- 3002807295
- 3014967149
- 3018182995
- 1051526
- 9617297
- 3030714745
- 3003935342
- 3009116370
- 3015440604
- 3006849754
- 3014967969
- 3011683674
- 3026311512
- 3016851379
- 3016084569
- 3023272531
- 9613910
- 3010049501
- 3009380093
- 3009756327
- 3013365802
- 3022159082
- 3010502940
- 3014315560
- 3007913880
- 1834331
- 1020279
- 1835444
- 1060840
- 3027339877
- 1835831
- 3010386387
- 3011388423
- 3003898228
- 3006946279
- 3002949614
- 3006217744
- 3015882686
Source Documents#
Other 510(k) Records For Product Code HSB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252025 | Active Intramedullary (AIM) Tibial Nail System | Satori Orthopaedics, Inc. | 2026-03-04 |
Legacy Summary#
summary