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
8281–8304 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 19, 2011
POLARIS SPINAL SYSTEM
K111957 · NKB
Biomet Spine (Ebi, LLC)
Orthopedic · 39d
Cleared Aug 19, 2011
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K112108 · MNI
Spineart
Orthopedic · 28d
Cleared Aug 18, 2011
SMR REVERSE SHOULDER SYSTEM
K110598 · PHX
Lima Corporate S.P.A.
Orthopedic · 169d
Cleared Aug 17, 2011
PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES)
K111135 · KWQ
K2m, Inc.
Orthopedic · 117d
Cleared Aug 17, 2011
REVOLVE ADDITIONAL IMPLANTS
K111449 · NKB
Globus Medical, Inc.
Orthopedic · 84d
Cleared Aug 17, 2011
REVERE CROSSTOP
K111479 · NKB
Globus Medical, Inc.
Orthopedic · 82d
Cleared Aug 16, 2011
TRUMATCH PERSONALIZED SOLUTIONS
K110397 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 186d
Cleared Aug 16, 2011
ENDO HEAD
K111145 · LZY
Medacta International
Orthopedic · 116d
Cleared Aug 11, 2011
UNIVERSAL CLAMP SPINAL FIXATION SYSTEM
K110348 · OWI
Zimmer Spine
Orthopedic · 185d
Cleared Aug 11, 2011
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K111127 · MNI
Spineart
Orthopedic · 112d
Cleared Aug 10, 2011
SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)
K111437 · HTO
Synthes USA Products, LLC
Orthopedic · 78d
Cleared Aug 09, 2011
CRESCENT (R) SPINAL SYSTEM TITANIUM
K110543 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 165d
Cleared Aug 09, 2011
SPEEDLOCK KNOTLESS FIXATION DEVICE
K111044 · MBI
ArthroCare Corporation
Orthopedic · 116d
Cleared Aug 09, 2011
METASURG SUBTALAR IMPLANT
K111265 · HWC
Metasurg
Orthopedic · 97d
Cleared Aug 08, 2011
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
K111540 · HRS
Synthes (Usa)
Orthopedic · 67d
Cleared Aug 08, 2011
ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR
K111590 · MBI
Rog Sports Medicine, Inc.
Orthopedic · 62d
Cleared Aug 08, 2011
Y-KNOT ALL-SUTURE ANCHOR MODEL HF13
K111779 · MBI
Conmed Linvatec
Orthopedic · 45d
Cleared Aug 08, 2011
T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP
K112059 · HSB
Stryker
Orthopedic · 20d
Cleared Aug 05, 2011
PERIMETER C SPINAL SYSTEM
K100967 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 484d
Cleared Aug 05, 2011
BRAINLAB TRAUMA
K110204 · OLO
Brainlab AG
Orthopedic · 193d
Cleared Aug 05, 2011
ORTHOPEDIATRICS BLADE PLATE SYSTEM
K110959 · HRS
OrthoPediatrics Corp.
Orthopedic · 122d
Cleared Aug 04, 2011
UNITED UTF STEM
K110245 · LPH
United Orthopedic Corporation
Orthopedic · 189d
Cleared Aug 04, 2011
AESCULAP SIBD XP SPINAL SYSTEM
K111122 · OVD
Aesculap Implant Systems, Inc.
Orthopedic · 105d
Cleared Aug 04, 2011
STRYKER SPINE POWER ADAPTOR (ACCESSORY INSTRUMENT)
K111478 · NKB
Stryker Corporation
Orthopedic · 69d