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
97–120 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 29, 2026
SPINEART Navigation Instrument System
K261205 · OLO
Spineart SA
Orthopedic · 107d
Cleared Jul 28, 2026
Xpert Ankle
K261511 · HRS
Newclip Technics
Orthopedic · 82d
Cleared Jul 28, 2026
TruLift Expandable System
K261430 · MAX
Life Spine, Inc.
Orthopedic · 89d
Cleared Jul 24, 2026
REMEDY POLY+PLUS SNAP FIT Acetabular Cup
K262290 · KWL
Osteoremedies, LLC
Orthopedic · 18d
Cleared Jul 24, 2026
Ion-L Navigated Instruments
K262121 · OLO
SurGenTec, LLC
Orthopedic · 31d
Cleared Jul 24, 2026
TMINI Miniature Robotic System
K261024 · OLO
THINK Surgical, Inc.
Orthopedic · 116d
Cleared Jul 24, 2026
QUATTRO Spinal system (Open Configuration)
K260362 · NKB
MANTIZ Co., Ltd.
Orthopedic · 170d
Cleared Jul 24, 2026
Tiger 2 System
K253943 · NKB
Zavation Medical Products, LLC
Orthopedic · 226d
Cleared Jul 23, 2026
Klassic Infection Spacer System
K261734 · JWH
Total Joint Orthopedics, Inc.
Orthopedic · 58d
Cleared Jul 23, 2026
3d Cage Cervical
K253041 · ODP
Fims Co., Ltd.
Orthopedic · 304d
Cleared Jul 22, 2026
E3D™-C Interbody System
K262094 · OVE
Evolution Spine
Orthopedic · 30d
Cleared Jul 22, 2026
Lapidus Screw Kit
K262075 · HWC
Relja Innovations, LLC
Orthopedic · 30d
Cleared Jul 22, 2026
Op.n™ Spine Navigation and Robotic Guidance
K261113 · OLO
Ecential Robotics
Orthopedic · 110d
Cleared Jul 22, 2026
Tornier Perform Advanced Glenoid
K260721 · KWS
Tornier, Inc.
Orthopedic · 139d
Cleared Jul 21, 2026
Versalock Proximal Tibial Plating System
K261406 · HRS
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 83d
Cleared Jul 20, 2026
Thunderbolt System
K261632 · MBI
Responsive Arthroscopy, Inc.
Orthopedic · 63d
Cleared Jul 17, 2026
Tritanium® C Anterior Cervical Cage
K262061 · ODP
Stryker Spine
Orthopedic · 29d
Cleared Jul 17, 2026
Catalyft PL Expandable Interbody System
K253011 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 301d
Not Cleared Jul 17, 2026
SportSuite Vision Software
DEN250040 · SIT
Stryker Endoscopy
Orthopedic · 318d
Cleared Jul 16, 2026
TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD)
K262032 · HRS
TriMed, Inc.
Orthopedic · 29d
Cleared Jul 16, 2026
Palisades™ Buttress Plate System
K261309 · KWQ
Bethesda Medical Devices, LLC
Orthopedic · 86d
Cleared Jul 16, 2026
Cable-Ready® Cable Grip System
K261271 · JDQ
Pioneer Surgical Technology, Inc.
Orthopedic · 90d
Cleared Jul 15, 2026
Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System
K261353 · OVD
Kyocera Medical Technologies, Inc.
Orthopedic · 82d
Cleared Jul 15, 2026
Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant
K252822 · PLR
Atlas Spine, Inc.
Orthopedic · 314d