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
3577–3600 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 17, 2019
ORTHOLOC™ SPS Shoulder Plating System
K191711 · HRS
Tornier, Inc.
Orthopedic · 21d
Cleared Jul 17, 2019
Xtreme-Loop
K191053 · MBI
Xiros, Ltd.
Orthopedic · 89d
Cleared Jul 16, 2019
EMPOWR Partial Knee
K191325 · HSX
Encore Medical, L.P.
Orthopedic · 61d
Cleared Jul 15, 2019
MicroPort CoCr Femoral Heads
K190123 · LPH
Microport Orthopedics, Inc.
Orthopedic · 171d
Cleared Jul 15, 2019
UNiD Patient-matched PLIF cage
K182158 · MAX
Medicrea International SA
Orthopedic · 340d
Cleared Jul 10, 2019
Nexxt Matrixx System
K191408 · MAX
Nexxt Spine, LLC
Orthopedic · 43d
Cleared Jul 10, 2019
Salvo™ Spine System
K191045 · NKB
Spine Wave, Inc.
Orthopedic · 82d
Cleared Jul 10, 2019
Velofix TLIF Cage
K183243 · MAX
U&I Corporation
Orthopedic · 231d
Cleared Jul 08, 2019
Materialise Glenoid Positioning System
K190286 · KWS
Materialise NV
Orthopedic · 147d
Cleared Jul 05, 2019
Harrier-SA Lumbar Interbody System
K191367 · MAX
Choice Spine, LLC
Orthopedic · 44d
Cleared Jul 05, 2019
Zimmer Guide Wire Devices
K191238 · HSB
Zimmer, Inc.
Orthopedic · 58d
Cleared Jul 05, 2019
Fortilink® IBF System with TETRAfuse®3D Technology, include the following...
K190498 · MAX
Pioneer Surgical Technology, Inc....
Orthopedic · 127d
Cleared Jul 05, 2019
OrthoPediatrics Cannulated Screw System
K190324 · HWC
OrthoPediatrics Corp.
Orthopedic · 142d
Cleared Jul 03, 2019
Infinity Fixation System
K191204 · MBI
Conmed Corporation
Orthopedic · 58d
Cleared Jul 03, 2019
NuVasive® Camber Laminoplasty System
K191169 · NQW
Nu Vasive, Incorporated
Orthopedic · 63d
Cleared Jul 03, 2019
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal...
K190959 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 82d
Cleared Jul 03, 2019
OsteoFab Suture Anchors
K190915 · MBI
Oxford Performance Materials, Inc.
Orthopedic · 85d
Cleared Jul 01, 2019
TriMed Nitinol Staple System
K190166 · JDR
TriMed, Inc.
Orthopedic · 151d
Cleared Jun 28, 2019
HEALIX ADVANCE Anchor with DYNA+TAPE Sutures
K191483 · MBI
Medos International SARL
Orthopedic · 24d
Cleared Jun 28, 2019
NAVIO
K191223 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 52d
Cleared Jun 28, 2019
MicroLink All-Suture Button Fixation System (Radiopaque)
K190582 · HTN
Conmed Corporation
Orthopedic · 114d
Cleared Jun 28, 2019
MicroLink All-Suture Button Fixation System (Radiolucent)
K190516 · HTN
Conmed Corporation
Orthopedic · 116d
Cleared Jun 28, 2019
TxTi IBF System
K183064 · MAX
Innovasis, Inc.
Orthopedic · 235d
Cleared Jun 25, 2019
WishBone Guided Growth System
K182704 · OBT
Wishbone Medical
Orthopedic · 271d