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
11185–11208 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 16, 2005
GAMMA3 NAIL SYSTEM
K043431 · HSB
Howmedica Osteonics Corp.
Orthopedic · 65d
Cleared Feb 16, 2005
EBI TROCHANTERIC NAIL SYSTEM
K050118 · HSB
Ebi, L.P.
Orthopedic · 29d
Cleared Feb 16, 2005
TECHTONIX SYSTEM
K050189 · KWP
Stryker Spine
Orthopedic · 20d
Cleared Feb 11, 2005
HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX DELTA) CERAMIC FEMORAL...
K041940 · LZO
Howmedica Osteonics Corp.
Orthopedic · 207d
Cleared Feb 11, 2005
STRYKER SPINE AVS TL PEEK SPACER
K042571 · MQP
Stryker Spine
Orthopedic · 143d
Cleared Feb 11, 2005
VANGUARD SSK KNEE SYSTEM
K042757 · JWH
Biomet, Inc.
Orthopedic · 130d
Cleared Feb 11, 2005
CORAIL AMT HIP PROSTHESIS
K042992 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 102d
Cleared Feb 11, 2005
EASYSPINE SYSTEM
K043094 · MNI
Ldr Spine USA
Orthopedic · 94d
Cleared Feb 11, 2005
E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT
K043289 · KTT
Signal Medical Corp.
Orthopedic · 74d
Cleared Feb 11, 2005
ASIAN INTRAMEDULLARY HIP SCREW NAILS
K050226 · HWC
Smith & Nephew, Inc.
Orthopedic · 10d
Cleared Feb 10, 2005
TRIDENT ACETABULAR SYSTEM
K033716 · LPH
Howmedica Osteonics Corp.
Orthopedic · 442d
Cleared Feb 10, 2005
APEX MODULAR HA HIP STEM
K043123 · LPH
Apex Surgical, LLC
Orthopedic · 90d
Cleared Feb 10, 2005
OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE
K043420 · MQV
Regeneration Technologies, Inc.
Orthopedic · 59d
Cleared Feb 10, 2005
CD HORIZON SPINAL SYSTEM
K050079 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Feb 09, 2005
SCORPIO NRG KNEE SYSTEM
K042343 · JWH
Howmedica Osteonics Corp.
Orthopedic · 163d
Cleared Feb 09, 2005
DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM
K043505 · KWT
Biomet, Inc.
Orthopedic · 51d
Cleared Feb 07, 2005
ATALIA TITANIUM SURGICAL MESH
K041798 · MQP
Us Spinal Technologies, LLC
Orthopedic · 220d
Cleared Feb 07, 2005
OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
K042073 · KWQ
Olsen Medical
Orthopedic · 189d
Cleared Feb 07, 2005
STEALTH FUSION SYSTEM, MODEL RR 1000
K043174 · KTT
R&R Medical, Inc.
Orthopedic · 83d
Cleared Feb 07, 2005
RABEA SPINAL IMPLANT
K043316 · MQP
Signus Medizintechnik GmbH
Orthopedic · 67d
Cleared Feb 07, 2005
NUVASIVE COROENT SYSTEM
K043405 · MQP
Nuvasive, Inc.
Orthopedic · 59d
Cleared Feb 03, 2005
PIONEER ANTERIOR CERVICAL PLATE SYSTEM
K043066 · KWQ
Pioneer Surgical Technology
Orthopedic · 87d
Cleared Feb 03, 2005
SYNTHES 3.5MM CORTEX SCREWS
K043185 · HWC
Synthes (Usa)
Orthopedic · 78d
Cleared Feb 03, 2005
SIGN FIN NAIL
K043200 · HSB
Surgical Implant Generation Network...
Orthopedic · 77d