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
9001–9024 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 01, 2009
AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS
K092419 · HRS
Howmedica Osteonics Corp.
Orthopedic · 26d
Cleared Aug 28, 2009
WAVEON WRX BONE FIXATION SYSTEM
K090304 · HRS
Sonoma Orthopedic Products, Inc.
Orthopedic · 203d
Cleared Aug 28, 2009
ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS
K091844 · MAI
Arthrex, Inc.
Orthopedic · 67d
Cleared Aug 27, 2009
WMT COMPOSITE DBM
K083270 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 294d
Cleared Aug 26, 2009
SIGN HIP CONSTRUCT (SHC), MODEL: 701
K083582 · KTT
Surgical Implant Generation Network...
Orthopedic · 265d
Cleared Aug 26, 2009
ARTHROSCOPE
K091398 · HRX
Orthopedic Sciences, Inc.
Orthopedic · 106d
Cleared Aug 25, 2009
PROFEMUR HIP SYSTEM MODULAR NECKS
K091423 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 104d
Cleared Aug 20, 2009
ADVANCE 913 MEDIAL PIVOT TIBIAL INSERT, ADVANCE 913 MEDIAL PIVOT TIBIAL BASE
K092201 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 29d
Cleared Aug 17, 2009
CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE
K091134 · KWQ
Custom Spine, Inc.
Orthopedic · 119d
Cleared Aug 17, 2009
BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL
K091976 · HSB
Biomet Trauma
Orthopedic · 47d
Cleared Aug 14, 2009
ASFORA BULLET CAGE SYSTEM
K090048 · MAX
Medical Designs, LLC
Orthopedic · 219d
Cleared Aug 14, 2009
MODIFICATION TO: TSRH SPINAL SYSTEM
K090740 · NKB
Medtronic Sofamor Danek
Orthopedic · 147d
Cleared Aug 14, 2009
MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000
K091763 · HTN
Instratek, Inc.
Orthopedic · 59d
Cleared Aug 13, 2009
REVERE 6.35 STABILIZATION SYSTEM
K091782 · NKB
Globus Medical, Inc.
Orthopedic · 57d
Cleared Aug 13, 2009
TRUSS THORACOLUMBAR PLATE SYSTEM
K092108 · KWQ
Globus Medical, Inc.
Orthopedic · 30d
Cleared Aug 12, 2009
LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331
K091453 · KRO
DePuy Orthopaedics, Inc.
Orthopedic · 86d
Cleared Aug 11, 2009
SENTINEL SPINAL SYSTEM
K090343 · KWP
Life Spine
Orthopedic · 182d
Cleared Aug 10, 2009
ACCELL EVO3C
K091193 · MBP
Isotis Orthobiologics, Inc.
Orthopedic · 109d
Cleared Aug 07, 2009
RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL...
K091041 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 116d
Cleared Aug 07, 2009
IBEX SPINAL SYSTEM
K091381 · MAX
Ebi, L.P.
Orthopedic · 88d
Cleared Aug 07, 2009
LAGUNA SIZE 8 PEDICLE SCREW SYSTEM
K091995 · NKB
Allez Spine, LLC
Orthopedic · 36d
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