Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

58 results for "Spineart"
25–48 of 58
Search insights Median review: 76d Cleared: 100% Top manufacturer: Spineart Lead specialty: Orthopedic
Cleared Mar 04, 2019
SCARLET® AC-T Secured Anterior Cervical Cage
K190322 · ODP
Spineart
Orthopedic · 19d
Cleared Feb 25, 2019
Perla® Posterior Cervico-Thoracic Fixation System
K190071 · NKG
Spineart
Orthopedic · 41d
Cleared Oct 09, 2018
Scarlet AL-T
K181818 · OVD
Spineart
Orthopedic · 92d
Cleared Jun 28, 2018
Juliet Ti
K181203 · MAX
Spineart
Orthopedic · 52d
Cleared Feb 26, 2018
TRYPTIK2 C-Plate Anterior Cervical Plate System
K171797 · KWQ
Spineart
Orthopedic · 255d
Cleared Jan 03, 2018
Juliet Ti LL
K173702 · MAX
Spineart
Orthopedic · 30d
Cleared Sep 29, 2017
SCARLET AC-T
K172065 · ODP
Spineart
Orthopedic · 84d
Cleared Sep 26, 2017
ROMEO® 2 Posterior Osteosynthesis System
K172101 · NKB
Spineart
Orthopedic · 76d
Cleared Sep 12, 2016
JULIET® LL Lateral Lumbar Cage
K161888 · MAX
Spineart
Orthopedic · 63d
Cleared Jul 15, 2016
Juliet® Ti
K153621 · MAX
Spineart
Orthopedic · 210d
Cleared Mar 28, 2016
TRYPTIK2C-plate Anterior Cervical Plate System
K153042 · KWQ
Spineart
Orthopedic · 161d
Cleared Jan 25, 2016
Perla Posterior Cervico-Thoracic Fixation system
K153386 · NKG
Spineart
Orthopedic · 63d
Cleared Jan 06, 2016
OTELO LL
K151104 · GAD
Spineart
General & Plastic Surgery · 257d
Cleared Sep 10, 2015
Romeo posterior osteosynthesis system
K151695 · MNH
Spineart
Orthopedic · 79d
Cleared Feb 23, 2015
SCARLET® AC-T Secured Anterior Cervical Cage
K143214 · OVE
Spineart
Orthopedic · 105d
Cleared Dec 01, 2014
JULIET LL
K141135 · MAX
Spineart
Orthopedic · 214d
Cleared Oct 14, 2014
JULIET PO
K142277 · MAX
Spineart
Orthopedic · 60d
Cleared Sep 29, 2014
SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION
K141314 · OVE
Spineart
Orthopedic · 132d
Cleared Sep 10, 2014
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS
K141835 · MNI
Spineart
Orthopedic · 65d
Cleared Aug 21, 2014
ROMEO 2 PAD POSTERIOR AXIAL DEVICE
K141508 · PEK
Spineart
Orthopedic · 76d
Cleared May 20, 2014
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K140948 · MNH
Spineart
Orthopedic · 36d
Cleared Apr 18, 2014
JULIET OL
K140474 · MAX
Spineart
Orthopedic · 52d
Cleared Feb 03, 2014
JULIET LL LATERAL LUMBAR CAGE
K133557 · MAX
Spineart
Orthopedic · 76d
Cleared May 31, 2013
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K130267 · MNH
Spineart
Orthopedic · 116d