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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,816 results
10537–10560 of 17,816
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 20, 2006
MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597,...
K061089 · KYI
Biopro, Inc.
Orthopedic · 63d
Cleared Jun 19, 2006
US SPINE FACET FIXATION SYSTEM
K061041 · MRW
Us Spine
Orthopedic · 66d
Cleared Jun 19, 2006
ACUTE BONE SCREW
K061206 · HWC
Acute Innovations, LLC
Orthopedic · 49d
Cleared Jun 16, 2006
OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT FIXATION ROD SYSTEM
K051965 · HSB
Merete Medical GmbH
Orthopedic · 331d
Cleared Jun 15, 2006
APEX KNEE SYSTEM
K060192 · JWH
Omni Life Science, Inc.
Orthopedic · 141d
Cleared Jun 15, 2006
MILAGRO INTERFERENCE SCREW
K060830 · HWC
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 80d
Cleared Jun 14, 2006
REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING
K060630 · LPH
Smith & Nephew, Inc.
Orthopedic · 97d
Cleared Jun 14, 2006
NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES
K061211 · HRS
Zimmer GmbH
Orthopedic · 44d
Cleared Jun 12, 2006
ULTRATINE TRANSBLEPH
K060248 · HWC
Coapt Systems, Inc.
Orthopedic · 132d
Cleared Jun 12, 2006
ULTRATINE FOREHEAD
K060249 · HWC
Coapt Systems, Inc.
Orthopedic · 132d
Cleared Jun 12, 2006
VERSA-DIAL HUMERAL HEAD PROSTHESIS
K060716 · MBF
Biomet Manufacturing Corp
Orthopedic · 87d
Cleared Jun 12, 2006
EXACTECH EQUINOXE SHOULDER STEMS
K061454 · HSD
Exactech, Inc.
Orthopedic · 18d
Cleared Jun 09, 2006
TRIDENT ANCHOR
K060914 · HWC
Johnson & Johnson Company
Orthopedic · 66d
Cleared Jun 08, 2006
SSP PEDICLE SCREW SYSTEM
K060118 · MNH
Specialty Spine Products, LLC
Orthopedic · 142d
Cleared Jun 08, 2006
ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017.
K060916 · MQP
Spinal Edge, LLC
Orthopedic · 65d
Cleared Jun 08, 2006
EBI ESL PEEK-OPTIMA SPINE SYSTEM
K061016 · MQP
Ebi, L.P.
Orthopedic · 56d
Cleared Jun 08, 2006
DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT
K061144 · MBB
DePuy Orthopaedics, Inc.
Orthopedic · 44d
Cleared Jun 08, 2006
KINSA SUTURE ANCHOR
K061154 · MBI
Smith & Nephew, Inc.
Orthopedic · 43d
Cleared Jun 08, 2006
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM FOR THE UPPER EXTREMITY
K061352 · HRS
Smith & Nephew, Inc.
Orthopedic · 24d
Cleared Jun 08, 2006
RETAIN RADIOLUCENT SPACER
K061380 · MQP
Globus Medical, Inc.
Orthopedic · 21d
Cleared Jun 06, 2006
FASTIN RC ANCHOR
K060664 · HWC
Depuy Mitek
Orthopedic · 85d
Cleared Jun 06, 2006
MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR
K060693 · HWC
Arthrotek, Inc.
Orthopedic · 83d
Cleared Jun 06, 2006
TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS...
K060963 · LXC
Twin Star Medical
Orthopedic · 60d
Cleared Jun 06, 2006
TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS
K061019 · JDS
Smith & Nephew, Inc.
Orthopedic · 54d