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
9241–9264 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 07, 2009
MONOPOLY PEDICLE SCREW SYSTEM
K092073 · NKB
Signus Medical
Orthopedic · 30d
Cleared Aug 06, 2009
MINI TIGHTROPE
K090107 · HTN
Arthrex, Inc.
Orthopedic · 203d
Cleared Aug 06, 2009
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K091365 · KWP
Medtronic Soafamor Danek
Orthopedic · 90d
Cleared Aug 05, 2009
CARDO MEDICAL ANTERIOR CERVICAL PLATE SYSTEM
K091396 · KWQ
Cardo Medical Corp.
Orthopedic · 87d
Cleared Aug 05, 2009
OPTILOCK PERIARTICULAR PLATING
K092078 · HRS
Biomet Trauma
Orthopedic · 27d
Cleared Aug 03, 2009
ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE
K083707 · HRX
Arthrex, Inc.
Orthopedic · 231d
Cleared Aug 03, 2009
MODIFICATION TO: DSS STABILIZATION SYSTEM
K091944 · NQP
Paradigm Spine, LLC
Orthopedic · 34d
Cleared Jul 31, 2009
TI-TAMED SPINAL SYSTEM
K070385 · NKB
Ti-Tamed (Pty), Ltd.
Orthopedic · 903d
Cleared Jul 31, 2009
PASS LP SPINAL SYSTEM
K083810 · MNI
Medicrea Technologies
Orthopedic · 221d
Cleared Jul 31, 2009
SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS
K090949 · HWC
Synthes (Usa)
Orthopedic · 119d
Cleared Jul 30, 2009
5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS
K090203 · NKB
Ebi, L.P.
Orthopedic · 184d
Cleared Jul 30, 2009
FORTEX PEDICLE SCREW SYSTEM
K090224 · MNH
X-Spine Systems, Inc.
Orthopedic · 181d
Cleared Jul 30, 2009
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063
K091190 · JDQ
Zimmer Spine, Inc.
Orthopedic · 98d
Cleared Jul 30, 2009
MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 9076
K091988 · MAX
Vertebral Technologies, Inc.
Orthopedic · 28d
Cleared Jul 30, 2009
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K092015 · HRS
Smith & Nephew, Inc.
Orthopedic · 24d
Cleared Jul 29, 2009
PANTA NAIL (DIA. 10MM), PANTA NAIL XL
K091788 · HSB
Newdeal Sas
Orthopedic · 42d
Cleared Jul 27, 2009
ALPINE PEDICLE SCREW SYSTEM
K090477 · MNH
Sanacor
Orthopedic · 153d
Cleared Jul 27, 2009
GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID
K092122 · KWS
DePuy Orthopaedics, Inc.
Orthopedic · 13d
Cleared Jul 24, 2009
NUBIC AND RABEA DEVICES
K082848 · ODP
Signus Medizintechnik GmbH
Orthopedic · 298d
Cleared Jul 24, 2009
SPINAL EDGE TITAN PEDICLE SCREW SYSTEM
K091110 · MNH
Spinal Edge, LLC
Orthopedic · 98d
Cleared Jul 24, 2009
EXTRAFIX EXTERNAL FIXATION SYSTEM
K091258 · KTT
Qfx Technologies, Inc.
Orthopedic · 86d
Cleared Jul 24, 2009
LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL...
K091294 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 81d
Cleared Jul 24, 2009
EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM
K091577 · HWC
Extremity Medical, LLC
Orthopedic · 52d
Cleared Jul 22, 2009
CONQUEST SPINAL SYSTEM
K090320 · NKB
Life Spine
Orthopedic · 163d