510(k) K193016
- Device
- PRECICE Bone Transport System
- Applicant
- NuVasive Specialized Orthopedics, Inc.
- 510(k) number
- K193016
- Product code
- HSB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-05-08
- Date received
- 2019-10-29
- 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
- Madison Heffron
- Address
- 101 Enterprise, Suite 100 Alisa Viejo CA US 92656 92656
FDA Registration Numbers#
- 3003525643
- 3016851379
- 9615128
- 3013055499
- 3021008900
- 3010370500
- 3006563559
- 3015876273
- 3015882686
- 3010400367
- 3026311512
- 3001239363
- 3009158523
- 3006487372
- 3015877656
- 2022435
- 2249615
- 3010120104
- 2953359
- 3031261833
- 3009971621
- 1643817
- 3009532798
- 3006272282
- 1529009
- 3009996260
- 8043792
- 3005061536
- 1834331
- 3005290844
- 9613350
- 3009756327
- 3009973505
- 3011534620
- 1818910
- 3014302784
- 3012755988
- 3015946784
- 3009540749
- 3010331645
- 3006128100
- 3007993775
- 3007597023
- 3027339877
- 3009973699
- 3009144915
- 3006001176
- 3012663306
- 3010065126
- 3016237080
- 2028632
- 3004153896
- 3008650117
- 3015869121
- 2031966
- 3006849754
- 3014967149
- 3006846753
- 3004976965
- 3010462278
- 3007923096
- 1424434
- 3009732568
- 3030714745
- 3043543260
- 3030926959
- 3006217744
- 3003477135
- 1649518
- 3011127597
- 2183449
- 3015869493
- 3011302692
- 1644408
- 3012724179
- 3009380093
- 3005144609
- 3006742481
- 3006946279
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#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases