FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
12553–12576 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Apr 02, 2002
4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B
K020043 · HWC
Arthrex, Inc.
Orthopedic · 85d
Cleared Apr 02, 2002
IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL...
K020221 · HRS
Biomet Orthopedics, Inc.
Orthopedic · 70d
Cleared Mar 29, 2002
UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM
K014302 · MNH
Pisharodi Surgicals, Inc.
Orthopedic · 88d
Cleared Mar 29, 2002
RESORBABLE LACTOSORB-L ACL CROSSPIN
K014305 · HTY
Arthrotek, Inc.
Orthopedic · 88d
Cleared Mar 29, 2002
MODIFICATION TO REFLEX ANTERIOR CERVICAL PLATE SYSTEM
K020650 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Mar 29, 2002
GAMMA 3 LAG SCREW
K020677 · HSB
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Mar 27, 2002
BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S
K014304 · HWC
Triage Medical, Inc.
Orthopedic · 86d
Cleared Mar 27, 2002
UNIVERSAL BONE PLATE III SYSTEM (UBP III)
K020611 · HRS
Spinal Concepts, Inc.
Orthopedic · 30d
Cleared Mar 26, 2002
BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL...
K014243 · HWC
Triage Medical, Inc.
Orthopedic · 90d