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
12913–12936 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 30, 2000
NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS
K002356 · KRR
Sulzer Orthopedics, Inc.
Orthopedic · 89d
Cleared Oct 30, 2000
SYNTHES USS (10.0MM SIDE OPENING SCREWS)
K003061 · KWQ
Synthes
Orthopedic · 28d
Cleared Oct 27, 2000
MITEK CUFFTACK
K003076 · MAI
Mitek Products
Orthopedic · 24d
Cleared Oct 25, 2000
NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA
K002335 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 85d
Cleared Oct 23, 2000
RADIONICS RF DISC CATHETER ELECTRODE SYSTEM
K001741 · HRX
Radionics, Inc.
Orthopedic · 137d
Cleared Oct 23, 2000
BROOKER FEMORAL NAILS
K002278 · HSB
Biomet Orthopedics, Inc.
Orthopedic · 89d
Cleared Oct 23, 2000
MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM
K002980 · KWQ
Ebi, L.P.
Orthopedic · 28d
Cleared Oct 19, 2000
GLOBAL SPINAL FIXATION SYSTEM
K001668 · MNH
D.K.M. Co., Ltd.
Orthopedic · 141d
Cleared Oct 17, 2000
SMALL STATURE USS
K994121 · MNI
Synthes (Usa)
Orthopedic · 316d
Cleared Oct 16, 2000
MODIFICATION TO ISOBAR SPINAL SYSTEM
K002959 · KWP
Encore Orthopedics, Inc.
Orthopedic · 24d
Cleared Oct 13, 2000
TC-PLUS SOLUTION KNEE
K000666 · JWH
Plus Orthopedics
Orthopedic · 228d
Cleared Oct 13, 2000
XIA SPINE SYSTEM
K002858 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Oct 13, 2000
PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
K002883 · KWA
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Oct 11, 2000
PINS AND WIRES
K002125 · HTY
Implant Resource, Inc.
Orthopedic · 89d
Cleared Oct 06, 2000
SPEEDLINK TRANSVERSE CONNECTOR
K002082 · KWP
Spinal Concepts, Inc.
Orthopedic · 88d
Cleared Oct 06, 2000
SPL CRIMP SYSTEM
K002110 · JDQ
Pioneer Surgical Technology
Orthopedic · 86d
Cleared Oct 06, 2000
INTERPORE CROSS ANTERIOR CERVICAL PLATE SYSTEM
K002592 · KWQ
Interpore Cross Intl.
Orthopedic · 46d
Cleared Oct 06, 2000
SYNTHES PROXIMAL HUMERAL NAIL
K002729 · JDS
Synthes (Usa)
Orthopedic · 35d
Cleared Oct 06, 2000
BIOMET BI-POLAR SHOULDER SYSTEM
K002998 · KWT
Biomet, Inc.
Orthopedic · 10d
Cleared Oct 05, 2000
ASCEND SPINAL FIXATION SYSTEM
K002069 · KWP
Spinal Innovations, LLC
Orthopedic · 90d
Cleared Oct 05, 2000
XIA SPINE SYSTEM
K002505 · KWP
Howmedica Osteonics Corp.
Orthopedic · 51d
Cleared Oct 04, 2000
BROOKER TIBIA NAILS
K002057 · HSB
Biomet Orthopedics, Inc.
Orthopedic · 90d
Cleared Oct 04, 2000
EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL
K002484 · JDX
Electro Medical Systems SA
Orthopedic · 51d
Cleared Oct 04, 2000
ASCENT XXL CLOSED BOX FEMORAL COMPONENT
K002772 · JWH
Biomet, Inc.
Orthopedic · 28d