Medical Device Manufacturer · US , Round Rock , TX

Neosteo - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2013
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
1-6 of 6
Cleared Feb 11, 2022
FlexitSystem Knee osteotomy system
K212545 · HRS
Orthopedic · 183d
Cleared Feb 28, 2020
Superelastic Staple
K192447 · JDR
Orthopedic · 175d
Cleared Aug 28, 2019
Interphalangeal Joint Fusion Device Range
K191424 · HWC
Orthopedic · 91d
Cleared Nov 25, 2015
SELF- COMPRESSIVE SCREW
K153182 · HWC
Orthopedic · 22d
Cleared May 08, 2015
Snap-Off Self-Compressive Screw
K150772 · HWC
Orthopedic · 45d
Cleared Aug 28, 2013
SELF-COMPRESSIVE SCREW
K131471 · HWC
Orthopedic · 98d
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