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
8353–8376 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 27, 2011
OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765...
K101459 · MAI
Smith & Nephew, Inc.
Orthopedic · 246d
Cleared Jan 27, 2011
NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY
K102722 · MQV
Synthes USA Products, LLC
Orthopedic · 128d
Cleared Jan 27, 2011
REDONDO-L
K103297 · MAX
Seaspine, Inc.
Orthopedic · 80d
Cleared Jan 26, 2011
CD HORIZON SPINAL SYSTEM
K102886 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 118d
Cleared Jan 26, 2011
CONSENSUS KNEE SYSTEM
K102927 · MBH
Consensus Orthopedics, Inc.
Orthopedic · 114d
Cleared Jan 25, 2011
ORTHOVITA PEEK SPACER
K101171 · ODP
Orthovita, Inc.
Orthopedic · 274d
Cleared Jan 25, 2011
FLAMENCO SPINAL FIXATION SYSTEM
K102853 · MNH
Ulrich GmbH & Co. KG
Orthopedic · 118d
Cleared Jan 24, 2011
TOTAL SHOULDER SYSTEM
K102670 · KWS
Shoulder Innovations, LLC
Orthopedic · 130d
Cleared Jan 24, 2011
KYPHON INFLATION SYRINGE
K103231 · HRX
Medtronic Spine, LLC
Orthopedic · 84d
Cleared Jan 24, 2011
APTUS ULNA PLATES
K103332 · HRS
Medartis AG
Orthopedic · 73d
Cleared Jan 21, 2011
EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM
K102870 · MNH
Exactech, Inc.
Orthopedic · 113d
Cleared Jan 21, 2011
2.4MM VA-LCP INTERCARPAL FUSION SYSTEM
K103243 · HRS
Synthes (Usa)
Orthopedic · 81d
Cleared Jan 21, 2011
TAPERLOC COMPLETE, SIZE 5 AND 6
K103755 · KWA
Biomet Manufacturing Corp
Orthopedic · 29d
Cleared Jan 20, 2011
EMERALD SPINAL SYSTEM
K101446 · MNH
Mazor Surgical Technologies , Ltd.
Orthopedic · 241d
Cleared Jan 20, 2011
ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES
K102743 · HWE
Ortho Solutions Limited
Orthopedic · 120d
Cleared Jan 19, 2011
SP-FIX SPINOUS PROCESS FIXATION PLATE
K102195 · KWP
Globus Medical, Inc.
Orthopedic · 168d
Cleared Jan 19, 2011
R3 XLPE ANTEVERTED LINERS
K102370 · MBL
Smith & Nephew, Inc.
Orthopedic · 152d
Cleared Jan 19, 2011
ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM
K103533 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 49d
Cleared Jan 18, 2011
ALIF SPINAL TRUSS INTERBODY FUSION DEVICE
K083894 · MAX
4-Web Spine, LLC
Orthopedic · 750d
Cleared Jan 18, 2011
VEPER SYSTEM, EXPEDIUM SYSTEM
K103133 · NKB
Depuy Spine, Inc.
Orthopedic · 85d
Cleared Jan 14, 2011
E1 AVANTAGE HEAD
K101336 · LPH
Biomet Manufacturing Corp
Orthopedic · 247d
Cleared Jan 14, 2011
ORTHOFLEX ROD
K102601 · KWH
Ortho-Pro, LLC
Orthopedic · 127d
Cleared Jan 14, 2011
HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010,...
K102885 · JEC
Stryker Corp.
Orthopedic · 106d
Cleared Jan 14, 2011
KING COBRA ANTERIOR CERVICAL PLATE
K103068 · KWQ
Eminent Spine
Orthopedic · 88d