Spinecraft, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Spinecraft, LLC - FDA 510(k) Cleared Devices
Recent clearances: ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System, ASTRA Spine System, ORIO-Ti Intervertebral Body Fusion Cage System
12
Total
12
Cleared
0
Denied
Spinecraft, LLC has 12 FDA 510(k) cleared orthopedic devices. Based in Westchester, US.
Last cleared in 2023. Active since 2010.
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 - Spinecraft, LLC
12 devices
Cleared
Jul 20, 2023
ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation...
Orthopedic
266d
Cleared
Dec 22, 2022
ASTRA Spine System
Orthopedic
59d
Cleared
Sep 30, 2021
ORIO-Ti Intervertebral Body Fusion Cage System
Orthopedic
100d
Cleared
Jun 03, 2021
ASTRA Spine System
Orthopedic
34d
Cleared
Jul 06, 2018
ASTRA-OCT Spine System
Orthopedic
45d
Cleared
May 22, 2015
APEX-DL Spine System
Orthopedic
149d
Cleared
May 19, 2015
ASTRA SPINE SYSTEM
Orthopedic
90d
Cleared
Dec 24, 2013
VELOX ANTERIOR CERVICAL PLATE SYSTEM
Orthopedic
210d
Cleared
Nov 20, 2013
APEX SPINE SYSTEM
Orthopedic
92d
Cleared
Jul 26, 2011
APEX SPINE SYSTEM
Orthopedic
117d
Cleared
Mar 15, 2011
ALTUM ANTERIOR CERVICAL PLATE
Orthopedic
106d
Cleared
Dec 10, 2010
APEX SPINE SYSTEM W/ COCR RODS
Orthopedic
101d