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
6625–6648 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 01, 2014
CASPIAN OCT SPINAL SYSTEM
K133288 · KWP
K2m, Inc.
Orthopedic · 249d
Cleared Jun 30, 2014
PRECICE TRAUMA NAIL SYSTEM
K141447 · HSB
Ellipse Technologies, Inc.
Orthopedic · 28d
Cleared Jun 30, 2014
DELTA TT ACETABULAR SYSTEM
K141395 · LPH
Lima Corporate S.P.A.
Orthopedic · 33d
Cleared Jun 30, 2014
MBD PLATE SYSTEM
K141045 · HRS
Mbd Medical, LLC
Orthopedic · 68d
Cleared Jun 30, 2014
ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM
K140833 · JWH
Conformis, Inc.
Orthopedic · 89d
Cleared Jun 30, 2014
EXACTECH TAPERED WEDGE FEMORAL STEM
K140674 · LZO
Exactech, Inc.
Orthopedic · 104d
Cleared Jun 30, 2014
SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION...
K133575 · MNH
Spinevision S.A.
Orthopedic · 222d
Cleared Jun 27, 2014
NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG
K140701 · OQG
Novosource, Inc.
Orthopedic · 99d
Cleared Jun 26, 2014
SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM
K141397 · MNI
Precision Spine, Inc.
Orthopedic · 29d
Cleared Jun 26, 2014
INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE...
K141376 · MNH
Nexxt Spine, LLC
Orthopedic · 30d
Cleared Jun 26, 2014
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
K141002 · HRX
Visionsense, Ltd.
Orthopedic · 69d
Cleared Jun 26, 2014
COROENT THORACOLUMBAR IMPLANTS
K140659 · MAX
Nu Vasive, Incorporated
Orthopedic · 104d
Cleared Jun 26, 2014
KANGLI PEDICLE SCREW SPINAL SYSTEM
K140053 · MNH
Suzhou Kangli Orthopaedics Instrument...
Orthopedic · 168d
Cleared Jun 26, 2014
MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS
K133579 · MBI
Pontis Orthopaedics, LLC
Orthopedic · 217d
Cleared Jun 26, 2014
DIAMOND RATTLESNAKE SYSTEM
K133194 · KWQ
Eminent Spine
Orthopedic · 252d
Cleared Jun 23, 2014
APTUS ULNA SHORTENING 2.5
K141232 · HRS
Medartis AG
Orthopedic · 41d
Cleared Jun 20, 2014
VARIAX 2 ONE THIRD TUBULAR PLATING SYSTEM
K141204 · HRS
Stryker Trauma AG
Orthopedic · 42d
Cleared Jun 20, 2014
AXSOS 3 TI LOCKING PLATE SYSTEM
K141121 · HRS
Stryker Trauma AG
Orthopedic · 51d
Cleared Jun 20, 2014
ENCOMPASS 10/12 HIP STEM
K132697 · LPH
Ortho Development Corp.
Orthopedic · 295d
Cleared Jun 19, 2014
OSSEOFLEX SB
K140937 · NDN
Osseon, LLC
Orthopedic · 69d
Cleared Jun 19, 2014
COSMOLOCK PEDICLE SCREW SYSTEM
K140678 · MNH
Kalitec Direct, LLC
Orthopedic · 93d
Cleared Jun 18, 2014
TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM
K141029 · PHX
Tornier, Inc.
Orthopedic · 57d
Cleared Jun 16, 2014
U2 FEMORAL COMPONENT, CR, CEMENTED
K140073 · JWH
United Orthopedic Corp.
Orthopedic · 154d
Cleared Jun 13, 2014
ACUMED HAND FRACTURE SYSTEM
K141383 · HRS
Acumed, LLC
Orthopedic · 17d