FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,766 results
5737–5760 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 29, 2015
LnK Posterior Cervical Fixation System
K143278 · KWP
L & K Biomed Co., Ltd.
Orthopedic · 257d
Cleared Jul 28, 2015
Smith and Nephew Legion Hinge Knee System
K151118 · KRO
Smith & Nephew
Orthopedic · 92d
Cleared Jul 28, 2015
Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and...
K151105 · MAI
Smith & Nephew, Inc.
Orthopedic · 95d
Cleared Jul 28, 2015
Piccolo Composite Nailing System
K151010 · HSB
CarboFix Orthopedics , Ltd.
Orthopedic · 104d
Cleared Jul 28, 2015
Hyper-C Anterior Cervical Plate System
K150759 · KWQ
Degen Medical
Orthopedic · 127d
Cleared Jul 28, 2015
2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors
K150715 · MBI
Tornier, Inc.
Orthopedic · 131d
Cleared Jul 28, 2015
Tyber Medical Wedge System
K150394 · PLF
Tyber Medical, LLC
Orthopedic · 160d
Cleared Jul 24, 2015
N-Force Fixation System
K151146 · HWC
Innovision, Inc.
Orthopedic · 86d
Cleared Jul 24, 2015
SureLock W Suture Anchor
K151068 · MBI
Cayenne Medical, Inc.
Orthopedic · 94d
Cleared Jul 23, 2015
KYPHON ELEMENT Inflatable Bone Tamp
K151532 · HRX
Medtronic, Inc.
Orthopedic · 45d
Cleared Jul 23, 2015
CinchLock Flex Knotless Suture Anchor
K151314 · MBI
Pivot Medical
Orthopedic · 66d
Cleared Jul 22, 2015
Rampart-T Interbody Fusion System
K151020 · MAX
Spineology, Inc.
Orthopedic · 97d
Cleared Jul 22, 2015
iFuse Implant System
K150875 · OUR
SI-BONE, Inc.
Orthopedic · 112d
Cleared Jul 22, 2015
PATHWAY ELIF
K143143 · MAX
Custom Spine, Inc.
Orthopedic · 261d
Cleared Jul 20, 2015
Exactech Alteon Monobloc Revision Stem
K150066 · LZO
Exactech, Inc.
Orthopedic · 188d
Cleared Jul 17, 2015
PROW FUSION
K151654 · MAX
Nlt Spine, Ltd.
Orthopedic · 29d
Cleared Jul 17, 2015
A-CIFT SoloFuse
K151198 · OVE
Spinefrontier, Inc.
Orthopedic · 73d
Cleared Jul 17, 2015
ProMIS Fixation System
K150380 · NKB
Premia Spine, Ltd.
Orthopedic · 154d
Cleared Jul 16, 2015
MultiFIX S Knotless Fixation System
K151660 · MBI
ArthroCare Corporation
Orthopedic · 27d
Cleared Jul 16, 2015
Refobacin Bone Cement R
K150850 · MBB
Biomet, Inc.
Orthopedic · 107d
Cleared Jul 15, 2015
LnK Cervical Interbody Fusion Cage System
K151677 · ODP
L & K Biomed Co., Ltd.
Orthopedic · 23d
Cleared Jul 15, 2015
Monster Screw System
K151418 · HWC
Paragon 28
Orthopedic · 48d
Cleared Jul 15, 2015
OsteoMed Cannulated Screw System
K151021 · HWC
Osteomed Corp.
Orthopedic · 90d
Cleared Jul 15, 2015
ACP 1 Anterior Cervical Plating System
K150700 · KWQ
Stryker Corporation
Orthopedic · 119d