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
5641–5664 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 28, 2015
ARIX Ankle System
K152158 · KTT
Jeil Medical Corporation
Orthopedic · 56d
Cleared Sep 25, 2015
Renovis Anterior Cervical Plate System
K152193 · KWQ
Renovis Surgical Technologies, Inc.
Orthopedic · 51d
Cleared Sep 25, 2015
X-spine Pedicle Screw System
K152132 · MNI
X-Spine Systems, Inc.
Orthopedic · 56d
Cleared Sep 25, 2015
NuVasive X-CORE Mini Cervical Expandable VBR System
K151651 · PLR
Nu Vasive, Incorporated
Orthopedic · 99d
Cleared Sep 25, 2015
DePuy Actis Duofox Hip Prosthesis
K150862 · MEH
DePuy Orthopaedics, Inc.
Orthopedic · 177d
Cleared Sep 25, 2015
U2 Femoral Component, CR, Porous Coated, Additional Sizes
K150832 · MBH
United Orthopedic Corporation
Orthopedic · 179d
Cleared Sep 25, 2015
U2 Total Knee System- Additional Sizes
K150829 · JWH
United Orthopedic Corporation
Orthopedic · 179d
Cleared Sep 25, 2015
Bluefin Interbody System
K143479 · MAX
Tides Medical
Orthopedic · 291d
Cleared Sep 24, 2015
Pyrenees Cervical Plate System
K152281 · KWQ
K2m
Orthopedic · 43d
Cleared Sep 24, 2015
Gemmed pedicle screw spinal system
K151592 · MNI
Suzhou Gemmed Medical Instrument Co.,...
Orthopedic · 104d
Cleared Sep 24, 2015
Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis
K151293 · KWS
Tornier S.A.S.
Orthopedic · 132d
Cleared Sep 24, 2015
neon3
K150650 · NKG
Ulrich GmbH & Co. KG
Orthopedic · 196d
Cleared Sep 23, 2015
CrossRoads Screw System
K152072 · HWC
Crossroads Extremity Systems, LLC
Orthopedic · 58d
Cleared Sep 23, 2015
Hedgehog Cervical Interbody Fusion Device
K143685 · ODP
Vertera, Inc.
Orthopedic · 273d
Cleared Sep 17, 2015
Reliance Spinal Screw System
K152131 · MNI
Reliance Medical Systems, LLC
Orthopedic · 48d
Cleared Sep 17, 2015
ODALYS Pedicle Screw System
K152098 · MNI
Kisco International
Orthopedic · 51d
Cleared Sep 17, 2015
Everest Spinal System
K151727 · NKB
K2m, Inc.
Orthopedic · 83d
Cleared Sep 17, 2015
LDR Spine ROI-C Cervical Cage System
K150765 · OVE
Ldr Spine USA
Orthopedic · 177d
Cleared Sep 16, 2015
RECON system - MPJ-Plates
K152142 · HRS
Normed Medizin-Technik GmbH
Orthopedic · 44d
Cleared Sep 16, 2015
Ackermann Intervertebral Body Fusion Device
K143450 · ODP
Ackermann Instrumente GmbH
Orthopedic · 288d
Cleared Sep 16, 2015
Partial Knee Application (PKA)
K142530 · OLO
Mako Surgical Corporation
Orthopedic · 372d
Cleared Sep 11, 2015
CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System
K150619 · ODP
Orthofix, Inc.
Orthopedic · 185d
Cleared Sep 10, 2015
Xenco Medical Cervical Interbody System (Argus)
K152302 · ODP
Xenco Medical, LLC
Orthopedic · 27d
Cleared Sep 10, 2015
Romeo posterior osteosynthesis system
K151695 · MNH
Spineart
Orthopedic · 79d