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
4753–4776 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 25, 2017
VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse...
K173095 · NKB
Medos International SARL
Orthopedic · 26d
Cleared Oct 25, 2017
CosmoLock Pedicle Screw System
K172808 · NKB
Kalitec Direct, LLC
Orthopedic · 37d
Cleared Oct 25, 2017
Treace Medical Concepts (TMC) Compression Screw System
K172617 · HWC
Treace Medical Concepts, Inc.
Orthopedic · 55d
Cleared Oct 25, 2017
Ortus™ Expandable Lumbar Interbody Fusion System
K172334 · MAX
Atlas Spine, Inc.
Orthopedic · 84d
Cleared Oct 25, 2017
Cortina™ Lumbar Cage System
K171914 · MAX
Neurostructures, Inc.
Orthopedic · 121d
Cleared Oct 24, 2017
UTS Stem
K172251 · LPH
United Orthopedic Corporation
Orthopedic · 90d
Cleared Oct 23, 2017
Liberty Anterior Cervical Plate
K172585 · KWQ
Valorus Spine
Orthopedic · 56d
Cleared Oct 23, 2017
AnyPlus® Spinal Fixation System
K172546 · NKB
GS Medical Co., Ltd.
Orthopedic · 61d
Cleared Oct 23, 2017
Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology
K172343 · MAX
Rti Surgical, Inc.
Orthopedic · 82d
Cleared Oct 23, 2017
MECRON Cannulated Screw System
K172213 · HWC
Merete GmbH
Orthopedic · 91d
Cleared Oct 23, 2017
KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set
K171938 · PML
Medtronic
Orthopedic · 117d
Cleared Oct 23, 2017
M-ARS ACL: Anatomic Ribbon Surgery System
K171640 · MBI
Medacta International S.A.
Orthopedic · 143d
Cleared Oct 23, 2017
Acapella Cervical Spacer System
K171489 · OVE
Choicespine, LP
Orthopedic · 154d
Cleared Oct 23, 2017
G3™ Active Plate® Miniature System
K171293 · HRS
Genesis Fracture Care, Inc.
Orthopedic · 174d
Cleared Oct 23, 2017
IRENE Cannulated Screw System
K170056 · HWC
Tianjin Zhengtian Medical Instrument...
Orthopedic · 290d
Cleared Oct 20, 2017
MyKnee PPS-Pin Positioners
K170106 · JWH
Medacta International S.A.
Orthopedic · 281d
Cleared Oct 18, 2017
Stryker Spine Navigation System with SpineMap 3D software application,...
K172034 · OLO
Stryker Corporation
Orthopedic · 105d
Cleared Oct 17, 2017
Bencox Mirabo Cup System
K172806 · LPH
Corentec Co., Ltd.
Orthopedic · 29d
Cleared Oct 16, 2017
BioWick X Implant with Driver
K172186 · MBI
Cayenne Medical, Inc.
Orthopedic · 88d
Cleared Oct 13, 2017
NOVOS-NAIL Limb Lengthening System (LLS)
K163653 · HSB
Smith & Nephew
Orthopedic · 294d
Cleared Oct 12, 2017
Mikron Spinal Fixation System
K171497 · MNI
Mikron Makina Sanayi Ticaret Co. , Ltd.
Orthopedic · 143d
Cleared Oct 12, 2017
Galaxy UNYCO System
K170146 · KTT
Orthofix Srl
Orthopedic · 268d
Cleared Oct 11, 2017
NuVasive® Modulus XLIF Interbody System
K172123 · MAX
Nu Vasive, Incorporated
Orthopedic · 89d
Cleared Oct 10, 2017
XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory
K172724 · NKB
Stryker Corporation
Orthopedic · 29d