FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
4225–4248 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 20, 2018
Chiral Surgical Pedicle Screw System
K181995 · NKB
Chiral Surgical
Orthopedic · 56d
Cleared Sep 20, 2018
Aequalis Flex Revive Shoulder System
K181420 · KWS
Tornier, Inc.
Orthopedic · 112d
Cleared Sep 20, 2018
MicroPort Orthopedics Total Hip Systems MR Labeling
K173898 · LZO
Microport Orthopedics Inc. (Mpo)
Orthopedic · 272d
Cleared Sep 19, 2018
Ortoma Treatment Solution - OTS
K181449 · OLO
Ortoma AB
Orthopedic · 110d
Cleared Sep 19, 2018
T2 STRATOSPHERE™ Expandable Corpectomy System
K181328 · MQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 124d
Cleared Sep 19, 2018
TirboLOX-C Cervical IBFD
K181229 · ODP
Captiva Spine, Inc.
Orthopedic · 133d
Cleared Sep 19, 2018
FORTIFY Corpectomy Spacers
K173982 · MQP
Globus Medical, Inc.
Orthopedic · 264d
Cleared Sep 18, 2018
Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine...
K181390 · NKB
OrthoPediatrics Corp.
Orthopedic · 112d
Cleared Sep 18, 2018
Sypher Spacer System
K181337 · MAX
Biogennix, LLC
Orthopedic · 120d
Cleared Sep 18, 2018
Tandry Locking Plate System
K171904 · HRS
Microware Precision Co., Ltd.
Orthopedic · 449d
Cleared Sep 17, 2018
PALACOS MV
K182260 · LOD
Heraeus Medical GmbH
Orthopedic · 27d
Cleared Sep 17, 2018
Ceracell Ortho Foam
K181721 · MQV
Curasan AG
Orthopedic · 80d
Cleared Sep 14, 2018
Prime E-CLASS XLPE Liner
K181598 · LZO
Microport Orthopedics, Inc.
Orthopedic · 88d
Cleared Sep 14, 2018
Impress SFS System
K173910 · JDQ
Cable Fix Medical, LLC
Orthopedic · 266d
Cleared Sep 13, 2018
MOSS VRS Spinal System
K181821 · NKB
Biedermann Motech GmbH & Co. KG
Orthopedic · 66d
Cleared Sep 13, 2018
DYNA-LINK ELITE Stand-Alone Anterior Lumbar System
K180215 · OVD
Life Spine, Inc.
Orthopedic · 231d
Cleared Sep 13, 2018
Sorrento Bioglass Bone Graft Substitute
K173933 · MQV
Xenco Medical, LLC
Orthopedic · 261d
Cleared Sep 12, 2018
PRODENSE Bone Graft Substitute
K181255 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 124d
Cleared Sep 12, 2018
BioSphere Flex
K173424 · MQV
Synergy Biomedical
Orthopedic · 315d
Cleared Sep 11, 2018
Renovis S180 Lateral Lumbar Interbody Fusion System
K181655 · MAX
Renovis Surgical Technologies
Orthopedic · 81d
Cleared Sep 11, 2018
LnK Lumbar Interbody Fusion Cage System
K181380 · MAX
L & K Biomed Co., Ltd.
Orthopedic · 110d
Cleared Sep 10, 2018
SECULOK™ ACP System
K182055 · KWQ
U&I Corporation
Orthopedic · 41d
Cleared Sep 07, 2018
SILVERBACK Gorilla Plating System
K182148 · HWC
Paragon 28, Inc.
Orthopedic · 30d
Cleared Sep 07, 2018
Corin Optimized Positioning System (OPS) Femoral
K181061 · LZO
Corin USA
Orthopedic · 137d