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
12385–12408 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 01, 2002
MODIFICATION TO EBI XFIX DFS SYSTEM
K014276 · KTT
Ebi, L.P.
Orthopedic · 64d
Cleared Feb 28, 2002
ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS
K012640 · HRX
Medical Instruments Technology, Inc.
Orthopedic · 199d
Cleared Feb 28, 2002
LORENZ SELF DRILLING SCREWS
K013954 · HWC
Walter Lorenz Surgical, Inc.
Orthopedic · 90d
Cleared Feb 27, 2002
EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER
K020291 · JDI
Exactech, Inc.
Orthopedic · 30d
Cleared Feb 26, 2002
BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
K013107 · HWC
Karl Storz Endoscopy
Orthopedic · 162d
Cleared Feb 26, 2002
MEDIAL ROTATION KNEE SYSTEM
K020214 · JWH
Engineering Consulting Services, Inc.
Orthopedic · 35d
Cleared Feb 26, 2002
SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE
K020352 · HWC
Unitedstates Surgical
Orthopedic · 22d
Cleared Feb 26, 2002
MSD WIRE SYSTEM
K020426 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 18d
Cleared Feb 25, 2002
TITANIUM RETROGRADE FEMORAL NAIL - 13 MM DIAMETER
K013923 · HSB
Biomet Orthopedics, Inc.
Orthopedic · 90d
Cleared Feb 22, 2002
SLIM GLIDING NAIL SYSTEM
K020240 · KTT
Plus Orthopedics
Orthopedic · 30d
Cleared Feb 22, 2002
WMT MODULAR ULNAR HEAD IMPLANT
K020274 · KXE
Wrightmedicaltechnologyinc
Orthopedic · 25d
Cleared Feb 21, 2002
TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODELS 8123,...
K020204 · MQP
Interpore Cross Intl.
Orthopedic · 30d
Cleared Feb 15, 2002
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
K020196 · MNH
Sulzer Spine-Tech
Orthopedic · 24d
Cleared Feb 14, 2002
MODIFICATION TO PASS SPINAL SYSTEM
K020236 · KWP
Encore Orthopedics, Inc.
Orthopedic · 22d
Cleared Feb 14, 2002
OSTEONICS SPINAL SYSTEM
K020293 · MNH
Howmedica Osteonics Corp.
Orthopedic · 17d
Cleared Feb 13, 2002
UNI-T SPINAL SYSTEM
K013301 · MNI
Spine Vision, Inc.
Orthopedic · 133d
Cleared Feb 13, 2002
P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM)
K013312 · KWP
Spine Vision, Inc.
Orthopedic · 132d
Cleared Feb 13, 2002
SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM
K013979 · KWQ
Spinal Concepts, Inc.
Orthopedic · 72d
Cleared Feb 13, 2002
ENDIUS CERVICAL PLATE SYSTEM
K014107 · KWQ
Endius, Inc.
Orthopedic · 62d
Cleared Feb 13, 2002
AOS CANNULATED BONE SCREW SYSTEM
K014185 · HWC
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 55d
Cleared Feb 12, 2002
BACFIX SPINAL FIXATION SYSTEM
K013887 · MNH
Spinal Concepts, Inc.
Orthopedic · 81d
Cleared Feb 12, 2002
TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601
K020083 · HRX
Tuta Healthcare Pty Limited
Orthopedic · 33d
Cleared Feb 12, 2002
NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA
K020295 · JWH
Implex Corp.
Orthopedic · 15d
Cleared Feb 11, 2002
KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP
K020170 · LPH
Encore Orthopedics, Inc.
Orthopedic · 25d