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
6889–6912 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 22, 2014
ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)
K133950 · HTY
Bioretec, Ltd.
Orthopedic · 30d
Cleared Jan 22, 2014
JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
K133152 · KRO
Stanmore Implants Worldwide , Ltd.
Orthopedic · 61d
Cleared Jan 22, 2014
MPACT EXTENSION
K132879 · LPH
Medacta International
Orthopedic · 131d
Cleared Jan 22, 2014
AESCULAP PEEK XP SPINAL IMPLANT SYSTEM
K132421 · MAX
Aesculap Implant Systems, Inc.
Orthopedic · 170d
Cleared Jan 22, 2014
KESTREL POSTERIOR CERVICAL SPINE SYSTEM
K132122 · KWP
Omni Surgical, LLC Dba Spine360
Orthopedic · 196d
Cleared Jan 22, 2014
BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER...
K131135 · MBB
Biomet Manufacturing Corp
Orthopedic · 275d
Cleared Jan 22, 2014
CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEM
K130613 · HWC
Laura Cattabriga
Orthopedic · 321d
Cleared Jan 17, 2014
ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEM
K133228 · LPH
Iconacy Orthopedic Implants, LLC
Orthopedic · 88d
Cleared Jan 17, 2014
BONE FRAGMENT AND FIXATION PLATES, SCREWS AND WASHERS
K130614 · HRS
Laura Cattabriga
Orthopedic · 316d
Cleared Jan 16, 2014
Q-FIX SUTURE ANCHOR, 1.8MM
K133727 · MBI
ArthroCare Corporation
Orthopedic · 41d
Cleared Jan 16, 2014
SYNAPSE SYSTEM
K133698 · KWP
Synthes USA Products, LLC
Orthopedic · 44d
Cleared Jan 16, 2014
DYNESYS TOP-LOADING SPINAL SYSTEM
K133164 · NQP
Zimmer Spine, Inc.
Orthopedic · 91d
Cleared Jan 16, 2014
OPTIO-C ANTERIOR CERVICAL SYSTEM
K132894 · OVE
Zimmer Spine, Inc.
Orthopedic · 122d
Cleared Jan 16, 2014
DOLPHIX EXTERNAL FIXATION SYSTEM
K132363 · KTT
Citieffe S.R.L.
Orthopedic · 170d
Cleared Jan 15, 2014
U2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENT
K131864 · JWH
United Orthopedic Corporation
Orthopedic · 205d
Cleared Jan 14, 2014
TIGER SPINE SYSTEM
K133369 · NKB
Corelink, LLC
Orthopedic · 74d
Cleared Jan 14, 2014
TASMIN R
K123758 · MQP
Signus Medizintechnik GmbH
Orthopedic · 403d
Cleared Jan 13, 2014
SPINESELECT POLYSCREW PEDICLE SCREW SYSTEM
K133066 · NKB
Spineselect, LLC
Orthopedic · 108d
Cleared Jan 13, 2014
SANTIS PEDICLE SCREW SYSTEM
K133063 · NKB
Lanterna Medical Technologies
Orthopedic · 108d
Cleared Jan 10, 2014
DIGIFIX EXTERNAL FIXATION SYSTEM
K132731 · JEC
Virak Orthopedic Research, LLC
Orthopedic · 129d
Cleared Jan 10, 2014
ANNEXTM ADJACENT LEVEL SYSTEM
K132403 · MNH
Spine Wave, Inc.
Orthopedic · 162d
Cleared Jan 10, 2014
BIOACTIVE BONE GRAFT PUTTY
K132071 · MQV
Biostructures, LLC
Orthopedic · 191d
Cleared Jan 09, 2014
HAMMERLOCK 2
K133520 · HTY
Biomedical Enterprises, Inc.
Orthopedic · 55d
Cleared Jan 09, 2014
RAMPART-L
K133371 · MAX
Spineology, Inc.
Orthopedic · 69d