FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,766 results
9025–9048 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Jul 22, 2009
ADKINS STRUT
K091058 · HRS
Biomet Microfixation, Inc.
Orthopedic · 100d
Cleared Jul 22, 2009
NUVASIVE SPHERX II SYSTEM
K091502 · NKB
Nuvasive, Inc.
Orthopedic · 62d
Cleared Jul 15, 2009
TREU
K083912 · HWC
Treu-Instrumente GmbH
Orthopedic · 197d