Medical Device Manufacturer · US , Alisa Viejo , CA

Nuvasive Specialized Orthopedics, Inc. - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 2016

Recent clearances: Precice Ankle Salvage System, Precice Intramedullary Limb Lengthening System, External Remote Controller ERC 4P

20
Total
20
Cleared
0
Denied

FDA 510(k) Regulatory Record - Nuvasive Specialized Orthopedics, Inc. Orthopedic

20 devices
1-20 of 20
Cleared Aug 29, 2023
Precice Ankle Salvage System
K230765 · HSB
Orthopedic · 162d
Cleared Mar 15, 2023
Precice Intramedullary Limb Lengthening System
K220234 · HSB
Orthopedic · 412d
Cleared Dec 22, 2020
External Remote Controller ERC 4P
K202348 · HSB
Orthopedic · 126d
Cleared Sep 16, 2020
Precice® Ankle Salvage System
K200430 · HSB
Orthopedic · 208d
Cleared Aug 10, 2020
Precice® Bone Transport System
K201567 · HSB
Orthopedic · 60d
Cleared Jul 30, 2020
MAGEC® System
K201543 · PGN
Orthopedic · 51d
Cleared May 08, 2020
PRECICE Bone Transport System
K193016 · HSB
Orthopedic · 192d
Cleared May 08, 2020
Precice® Screws
K193617 · HSB
Orthopedic · 134d
Cleared Nov 07, 2019
PRECICE Plating System
K192181 · KTT
Orthopedic · 87d
Cleared Sep 26, 2019
PRECICE System
K191336 · HSB
Orthopedic · 132d
Cleared Feb 05, 2019
PRECICE® BONE TRANSPORT™ System
K182170 · HSB
Orthopedic · 179d
Cleared Apr 03, 2018
PRECICE STRYDE System
K180503 · HSB
Orthopedic · 36d
Cleared Dec 01, 2017
PRECICE System
K173129 · HSB
Orthopedic · 63d
Cleared Sep 25, 2017
PRECICE System
K172628 · HSB
Orthopedic · 24d
Cleared Aug 24, 2017
PRECICE UNYTE System
K172061 · HSB
Orthopedic · 48d
Cleared Jun 09, 2017
PRECICE Intramedullary Limb Lengthening System
K170169 · HSB
Orthopedic · 141d
Cleared Apr 06, 2017
PRECICE UNYTE CoCr System
K162927 · HSB
Orthopedic · 169d
Cleared Mar 07, 2017
PRECICE Intramedullary Limb Lengthening System
K170346 · HSB
Orthopedic · 33d
Cleared Oct 21, 2016
MAGEC® Spinal Bracing and Distraction System
K160352 · PGN
Orthopedic · 256d
Cleared Sep 02, 2016
MAGEC® Spinal Bracing and Distraction System
K161751 · PGN
Orthopedic · 70d
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