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
11305–11328 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 18, 2005
INION OTPS BIODEGRADABLE MINI PLATING SYSTEM
K043142 · HWC
Inion , Ltd.
Orthopedic · 95d
Cleared Feb 18, 2005
BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B
K043145 · HTN
Arthrex, Inc.
Orthopedic · 95d
Cleared Feb 18, 2005
BLAKSTONE LAMINOPLASTY FIXATION SYSTEM
K043338 · NQW
Blackstone Medical, Inc.
Orthopedic · 77d
Cleared Feb 18, 2005
4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N
K043351 · MRW
Triage Medical, Inc.
Orthopedic · 74d
Cleared Feb 18, 2005
SMITH & NEPHEW, INC. REVISION KNEE SYSTEM
K043440 · JWH
Smith & Nephew, Inc.
Orthopedic · 66d
Cleared Feb 18, 2005
ROC LUMBAR PLATING SYSTEM
K050078 · MNH
Alphatec/Nexmed
Orthopedic · 36d
Cleared Feb 18, 2005
MODIFICATION TO TSRH SPINAL SYSTEM
K050282 · NKB
Medtronic Sofamor Danek
Orthopedic · 11d
Cleared Feb 17, 2005
MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM
K042928 · MNH
U&I Corp.
Orthopedic · 118d
Cleared Feb 17, 2005
BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS
K043100 · MBF
Biomet, Inc.
Orthopedic · 100d
Cleared Feb 17, 2005
RESOFIX BIOABSORBABLE EXPANSION BOLT
K043411 · HTN
Resofix, Inc.
Orthopedic · 69d
Cleared Feb 17, 2005
MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM
K050117 · KWQ
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Feb 16, 2005
TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS
K043248 · HTN
Arthrex, Inc.
Orthopedic · 85d
Cleared Feb 16, 2005
MODIFICATION TO: HEALOS BONE GRAFT MATERIAL
K043308 · MQV
Depuy Spine, Inc.
Orthopedic · 77d
Cleared Feb 16, 2005
DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING
K043374 · MBH
Howmedica Osteonics Corp.
Orthopedic · 70d
Cleared Feb 16, 2005
OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC
K043421 · MQV
Regeneration Technologies, Inc.
Orthopedic · 65d
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