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
12841–12864 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 01, 2001
MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR
K012255 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 14d
Cleared Jul 31, 2001
HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
K011354 · HRS
Dj Orthopedics, LLC
Orthopedic · 89d
Cleared Jul 31, 2001
SUMMIT DUOFIX HIP PROSTHESIS
K011489 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 77d
Cleared Jul 31, 2001
RESORBABLE BONE PINS
K011522 · HTY
Biomet, Inc.
Orthopedic · 75d
Cleared Jul 31, 2001
PASS SPINAL SYSTEM
K012175 · MNI
Encore Orthopedics, Inc.
Orthopedic · 19d
Cleared Jul 31, 2001
OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES
K012251 · JWH
Exactech, Inc.
Orthopedic · 13d
Cleared Jul 27, 2001
SYNTHES CURVED RECONSTRUCTION PLATE
K011334 · HRS
Synthes (Usa)
Orthopedic · 86d
Cleared Jul 27, 2001
SYNTHS ONE-THIRD TUBULAR DCL PLATE
K011335 · HRS
Synthes (Usa)
Orthopedic · 86d
Cleared Jul 26, 2001
METRONIC SOFAMOR DANEK CEMENT RESTRICTOR
K011998 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Jul 26, 2001
THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND...
K012095 · JWH
Implex Corp.
Orthopedic · 21d
Cleared Jul 25, 2001
EBI XFIX DFS SYSTEM
K012024 · KTT
Ebi, L.P.
Orthopedic · 27d
Cleared Jul 23, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K011830 · KWP
Endius, Inc.
Orthopedic · 41d
Cleared Jul 20, 2001
ARTHROSCOPES
K003831 · HRX
Global Endoscopy, Inc.
Orthopedic · 221d
Cleared Jul 20, 2001
MACROPORE OS SPINAL SYSTEM
K010911 · KWQ
Macropore Biosurgery, Inc.
Orthopedic · 116d
Cleared Jul 20, 2001
NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM
K011118 · HRS
Osteomedics
Orthopedic · 99d
Cleared Jul 20, 2001
STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX
K011319 · JDW
Stryker Endoscopy
Orthopedic · 80d
Cleared Jul 20, 2001
COLOR BUFFED (CB) DDH FEMORAL STEM
K012019 · JDI
Biomet, Inc.
Orthopedic · 22d
Cleared Jul 20, 2001
MODIFICATION TO XIA SPINE SYSTEM
K012027 · MNH
Howmedica Osteonics
Orthopedic · 22d
Cleared Jul 19, 2001
PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075,...
K004003 · MQV
Interpore Cross Intl.
Orthopedic · 206d
Cleared Jul 19, 2001
NEXGEN PRIMARY POROUS PATELLA, MODEL...
K011904 · JWH
Implex Corp.
Orthopedic · 30d
Cleared Jul 19, 2001
SYNTHES CERVIFIX SYSTEM
K011969 · KWP
Synthes (Usa)
Orthopedic · 24d
Cleared Jul 18, 2001
SURGICAL DYNAMICS MESH CAGE SYSTEM
K003709 · MQP
United States Surgical, A Division of...
Orthopedic · 229d
Cleared Jul 18, 2001
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K010681 · KWP
Depuyacromed
Orthopedic · 133d
Cleared Jul 18, 2001
BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER
K011455 · JDI
Biomet, Inc.
Orthopedic · 68d