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."
1–24 of 57
Search insights Median review: 86d Cleared: 100% Top manufacturer: Orthofix, Inc. Lead specialty: Orthopedic
Cleared May 28, 2024
PILLAR SA Ti Spacer System (82-XXX)
K240749 · MAX
Orthofix, Inc.
Orthopedic · 70d
Cleared Aug 31, 2021
CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini...
K211704 · ODP
Orthofix, Inc.
Orthopedic · 89d
Cleared Jul 30, 2021
Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS),...
K211710 · NKG
Orthofix, Inc.
Orthopedic · 57d
Cleared Mar 25, 2021
FIREBIRD SI Fusion System
K210667 · OUR
Orthofix, Inc.
Orthopedic · 20d
Cleared Mar 18, 2021
CONSTRUX Mini Ti Spacer System
K203342 · ODP
Orthofix, Inc.
Orthopedic · 125d
Cleared Mar 03, 2021
FORZA Ti Spacer System
K203576 · MAX
Orthofix, Inc.
Orthopedic · 86d
Cleared Nov 18, 2020
FIREBIRD SI Fusion System
K203138 · OUR
Orthofix, Inc.
Orthopedic · 29d
Cleared Oct 29, 2020
CONSTRUX Mini PEEK Spacer System
K202949 · ODP
Orthofix, Inc.
Orthopedic · 29d
Cleared Oct 14, 2020
CONSTRUX Mini PTC Spacer System
K202666 · ODP
Orthofix, Inc.
Orthopedic · 30d
Cleared Sep 15, 2020
FIREBIRD SI Fusion System
K201664 · OUR
Orthofix, Inc.
Orthopedic · 88d
Cleared Jun 15, 2020
Centurion POCT System
K201481 · NKG
Orthofix, Inc.
Orthopedic · 11d
Cleared May 01, 2020
O-Genesis Graft Delivery System
K200606 · FMF
Orthofix, Inc.
General & Plastic Surgery · 53d
Cleared Apr 09, 2020
CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC...
K200052 · ODP
Orthofix, Inc.
Orthopedic · 90d
Cleared Apr 02, 2020
FIREBIRD SI Fusion System
K200696 · OUR
Orthofix, Inc.
Orthopedic · 16d
Cleared May 22, 2019
Connector System
K190751 · NKG
Orthofix, Inc.
Orthopedic · 58d
Cleared Apr 30, 2019
SambaScrew 3D SI Fusion System
K183342 · OUR
Orthofix, Inc.
Orthopedic · 148d
Cleared Aug 24, 2018
Firebird® Spinal Fixation Systems: Firebird System
K180179 · NKB
Orthofix, Inc.
Orthopedic · 213d
Cleared Mar 08, 2018
Navigated Instrument System
K172115 · OLO
Orthofix, Inc.
Orthopedic · 238d
Cleared Jan 22, 2018
Centurion POCT System
K180025 · NKG
Orthofix, Inc.
Orthopedic · 19d
Cleared Jan 19, 2018
FORZA® XP Expandable Spacer System
K172696 · MAX
Orthofix, Inc.
Orthopedic · 134d
Cleared Nov 02, 2017
CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC...
K172437 · ODP
Orthofix, Inc.
Orthopedic · 83d
Cleared Aug 18, 2017
Connector System
K172194 · NKG
Orthofix, Inc.
Orthopedic · 28d
Cleared May 11, 2017
Connector System
K170647 · NKG
Orthofix, Inc.
Orthopedic · 69d
Cleared May 05, 2017
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS...
K171082 · NKB
Orthofix, Inc.
Orthopedic · 24d