Medical Device Manufacturer · US , Red Bank , NJ

Nextremity Solutions, Inc. - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 2014
17
Total
17
Cleared
0
Denied

Nextremity Solutions, Inc. has 17 FDA 510(k) cleared orthopedic devices. Based in Red Bank, US.

Last cleared in 2022. Active since 2014.

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 - Nextremity Solutions, Inc.
17 devices
1-17 of 17
Cleared Nov 04, 2022
Nextra CH Cannulated Hammertoe System
K221610 · HWC
Orthopedic · 154d
Cleared May 20, 2022
CalcShift™ Displacement Calcaneal Osteotomy System
K212979 · HRS
Orthopedic · 245d
Cleared Mar 22, 2022
StealthFix Intraosseous Fixation System
K220181 · JDR
Orthopedic · 60d
Cleared Dec 21, 2021
InCore Subtalar System
K213301 · HWC
Orthopedic · 81d
Cleared Dec 09, 2021
Nextra CH Cannulated Hammertoe System
K213530 · HWC
Orthopedic · 34d
Cleared Nov 18, 2021
Stratum® Ankle Fusion Plating System
K212640 · HRS
General Hospital · 90d
Cleared Sep 23, 2021
Nexta PEEK Hammertoe Correction System
K211996 · HWC
Orthopedic · 87d
Cleared Jul 27, 2020
Stratum™ Reduced Size Foot Plating System
K200785 · HRS
Orthopedic · 123d
Cleared Jun 26, 2020
DuoHex CH Cannulated Hammertoe System
K200840 · HWC
Orthopedic · 87d
Cleared May 13, 2020
InCore MPJ System
K200124 · HWC
Orthopedic · 113d
Cleared Dec 31, 2019
InCore TMT System
K192578 · HWC
Orthopedic · 103d
Cleared May 24, 2019
InCore® Lapidus Sterile Kits
K190231 · HWC
Orthopedic · 107d
Cleared Nov 16, 2018
Stratum™ Foot Plating System
K182201 · HRS
Orthopedic · 94d
Cleared Apr 25, 2018
InCore® Lapidus System
K180257 · HWC
Orthopedic · 85d
Cleared Dec 21, 2015
AXI+LINE Proximal Bunion Correction System
K152548 · HRS
Orthopedic · 104d
Cleared Sep 04, 2015
Arcus Staple System
K151160 · JDR
Orthopedic · 126d
Cleared May 14, 2014
MSP METATARSAL SHORTENING SYSTEM
K140724 · HRS
Orthopedic · 54d
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