FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,850 results
12409–12432 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 02, 2002
RPX TITANIUM CEMNT RESTRICTOR
K020344 · JDK
Sulzer Spine-Tech
Orthopedic · 90d
Cleared May 01, 2002
FIXATION (STEINMANN) PINS
K013888 · HTY
Miltex, Inc.
Orthopedic · 159d
Cleared Apr 29, 2002
CLEARVIEW WRIST FIXATOR
K020311 · KTT
Rigid FX Orthopedics, Incorporated
Orthopedic · 90d
Cleared Apr 26, 2002
SUPER EON PLUS FEMORAL STEMS
K020989 · JDI
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Apr 25, 2002
S2 FEMORAL NAIL
K021026 · HSB
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared Apr 25, 2002
S2 TIBIAL NAIL
K021027 · HSB
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared Apr 22, 2002
SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP)
K020244 · KWQ
Synthes Spine
Orthopedic · 88d
Cleared Apr 22, 2002
DISTAL RADIUS PLATING SYSTEM
K020819 · HRS
Biomet, Inc.
Orthopedic · 40d
Cleared Apr 16, 2002
SYNTHES VERTEBRAL SPACER TI
K020152 · MQP
Synthes (Usa)
Orthopedic · 89d
Cleared Apr 16, 2002
TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM
K020963 · MEH
Biomet Orthopedics, Inc.
Orthopedic · 22d
Cleared Apr 15, 2002
SPIRAL RADIUS 90-D RODDING SYSTEM
K020134 · KWP
United States Surgical, A Division of...
Orthopedic · 90d
Cleared Apr 15, 2002
ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM
K020145 · LPH
Orthopaedic Innovations, Inc.
Orthopedic · 89d
Cleared Apr 15, 2002
CONSENSUS ACETABLAR SHELL, TI COATED
K020153 · LPH
Hayes Medical, Inc.
Orthopedic · 89d
Cleared Apr 15, 2002
SYNTHES DUAL-OPENING USS
K020517 · MNI
Synthes (Usa)
Orthopedic · 55d
Cleared Apr 15, 2002
NBX - NON-BRIDGING EXTERNAL FIXATOR
K020905 · LXT
Biomet Orthopedics, Inc.
Orthopedic · 26d
Cleared Apr 11, 2002
AVON PATELLAR COMPONENT
K020841 · KRR
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared Apr 05, 2002
ENVISION ANTERIOR CERVICAL PLATE SYSTEM
K020649 · KWQ
Ortho Development Corp.
Orthopedic · 36d
Cleared Apr 04, 2002
LONG LENGTH GAMMA NAIL
K020773 · HSB
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared Apr 04, 2002
MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS)
K020970 · JDI
Biomet, Inc.
Orthopedic · 9d
Cleared Apr 03, 2002
2 PIECE MODULAR HIP STEM
K013106 · LZO
Howmedica Osteonics Corp.
Orthopedic · 198d
Cleared Apr 03, 2002
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW
K020674 · MNH
Blackstone Medical, Inc.
Orthopedic · 33d
Cleared Apr 03, 2002
EBI OMEGA21 SPINAL FIXATION SYSTEM
K020681 · MNH
Ebi, L.P.
Orthopedic · 30d
Cleared Apr 03, 2002
HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR
K020688 · HRX
Hydrocision, Inc.
Orthopedic · 30d
Cleared Apr 03, 2002
POWER TEK II
K020761 · HRX
Biomet, Inc.
Orthopedic · 27d