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

Nuvasive Specialized Orthopedics, Inc. has 20 FDA 510(k) cleared orthopedic devices. Based in Alisa Viejo, US.

Last cleared in 2023. Active since 2016.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

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

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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