Neosteo is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Neosteo - FDA 510(k) Cleared Devices
Recent clearances: FlexitSystem Knee osteotomy system, Superelastic Staple, Interphalangeal Joint Fusion Device Range
6
Total
6
Cleared
0
Denied
Neosteo has 6 FDA 510(k) cleared medical devices. Based in Round Rock, US.
Last cleared in 2022. Active since 2013. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Neosteo Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by The OrthoMedix Group, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Neosteo
6 devices
Cleared
Feb 11, 2022
FlexitSystem Knee osteotomy system
Orthopedic
183d
Cleared
Feb 28, 2020
Superelastic Staple
Orthopedic
175d
Cleared
Aug 28, 2019
Interphalangeal Joint Fusion Device Range
Orthopedic
91d
Cleared
Nov 25, 2015
SELF- COMPRESSIVE SCREW
Orthopedic
22d
Cleared
May 08, 2015
Snap-Off Self-Compressive Screw
Orthopedic
45d
Cleared
Aug 28, 2013
SELF-COMPRESSIVE SCREW
Orthopedic
98d