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

57 results for "Orthofix, Inc."
25–48 of 57
Search insights Median review: 86d Cleared: 100% Top manufacturer: Orthofix, Inc. Lead specialty: Orthopedic
Cleared Mar 13, 2017
Navigated Instrument System
K162921 · OLO
Orthofix, Inc.
Orthopedic · 146d
Cleared Dec 22, 2016
FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System,...
K162446 · MAX
Orthofix, Inc.
Orthopedic · 112d
Cleared Dec 16, 2016
CETRA Anterior Cervical Plate System
K162638 · KWQ
Orthofix, Inc.
Orthopedic · 85d
Cleared Sep 08, 2016
PILLAR SA PTC
K161129 · OVD
Orthofix, Inc.
Orthopedic · 140d
Cleared Jun 17, 2016
Cervical Stand Alone System
K161280 · OVE
Orthofix, Inc.
Orthopedic · 42d
Cleared Jan 29, 2016
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System
K153428 · NKB
Orthofix, Inc.
Orthopedic · 65d
Cleared Jan 14, 2016
FORZA PTC Spacer System
K152475 · MAX
Orthofix, Inc.
Orthopedic · 136d
Cleared Sep 11, 2015
CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System
K150619 · ODP
Orthofix, Inc.
Orthopedic · 185d
Cleared Jul 07, 2015
Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System
K151488 · NKB
Orthofix, Inc.
Orthopedic · 35d
Cleared May 29, 2015
Azure Anterior Cervical Plate System
K143028 · KWQ
Orthofix, Inc.
Orthopedic · 220d
Cleared May 15, 2015
Centurion POCT System
K150822 · NKG
Orthofix, Inc.
Orthopedic · 49d
Cleared Jan 08, 2015
CONSTRUX MINI PEEK
K142152 · ODP
Orthofix, Inc.
Orthopedic · 155d
Cleared Jan 02, 2015
FIREBIRD SPINAL FIXATION SYSTEM
K141186 · NKB
Orthofix, Inc.
Orthopedic · 240d
Cleared Jul 02, 2014
SKYHAWK LATERAL PLATE SYSTEM
K140260 · KWQ
Orthofix, Inc.
Orthopedic · 149d
Cleared May 27, 2014
SKYHAWK INTERBODY FUSION SYSTEM
K140709 · MAX
Orthofix, Inc.
Orthopedic · 67d
Cleared Apr 14, 2014
CERVICAL STAND ALONE SYSTEM
K132999 · OVE
Orthofix, Inc.
Orthopedic · 202d
Cleared Jan 30, 2014
CENTURION POCT SYSTEM
K131833 · KWP
Orthofix, Inc.
Orthopedic · 224d
Cleared Aug 07, 2013
FIREBIRD SPINAL FIXATION SYSTEM
K130932 · NKB
Orthofix, Inc.
Orthopedic · 125d
Cleared May 07, 2013
AZURE ANTERIOR CERVICAL PLATE SYSTEM
K130825 · KWQ
Orthofix, Inc.
Orthopedic · 42d
Cleared Jul 20, 2012
ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM)
K121658 · KWQ
Orthofix, Inc.
Orthopedic · 45d
Cleared Feb 16, 2012
ICON (TM) MODULAR PEDICLE SCREW SYSTEM
K111448 · NKB
Orthofix, Inc.
Orthopedic · 268d
Cleared Jun 21, 2011
GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)
K110805 · OBT
Orthofix, Inc.
Orthopedic · 90d
Cleared May 24, 2011
ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME...
K111183 · KWP
Orthofix, Inc.
Orthopedic · 27d
Cleared Mar 23, 2011
FORZA SPACER SYSTEM
K103111 · MAX
Orthofix, Inc.
Orthopedic · 153d