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
12505–12528 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 04, 2002
UNICONDYLAR KNEE
K020741 · HRY
Encore Orthopedics, Inc.
Orthopedic · 90d
Cleared Jun 03, 2002
REPROCESSED ARTHROSCOPIC SHAPERS
K012667 · HRX
Surgical Instruments Service and...
Orthopedic · 294d
Cleared May 31, 2002
SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06
K021379 · MNI
Ortho Tec, LLC
Orthopedic · 30d
Cleared May 31, 2002
HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED...
K021403 · MEH
Biomet Orthopedics, Inc.
Orthopedic · 29d
Cleared May 28, 2002
TSRH SPINAL SYSTEM
K020699 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 88d
Cleared May 28, 2002
OSS LES PROXIMAL FEMORAL COMPONENT
K021380 · JDI
Biomet, Inc.
Orthopedic · 27d
Cleared May 24, 2002
G4 SLEEVED NAIL
K020962 · HSB
Biomet Manufacturing, Inc.
Orthopedic · 60d
Cleared May 23, 2002
APATIGHT HA-BONE GRAFT SUBSTITUTE
K013960 · MQV
Cerabio, LLC
Orthopedic · 171d
Cleared May 23, 2002
BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)
K020620 · KWQ
Blackstone Medical, Inc.
Orthopedic · 87d
Cleared May 23, 2002
EBI DFS OPTIROM ELBOW FIXATOR
K021312 · KTT
Ebi, L.P.
Orthopedic · 28d
Cleared May 23, 2002
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM)
K021324 · HSB
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 27d
Cleared May 22, 2002
BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)
K020600 · KWQ
Blackstone Medical, Inc.
Orthopedic · 89d
Cleared May 21, 2002
KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT
K013982 · KRR
Kinamed, Inc.
Orthopedic · 169d
Cleared May 21, 2002
36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
K021310 · JDI
Howmedica Osteonics Corp.
Orthopedic · 26d
Cleared May 20, 2002
AGILITY ANKLE REVISION PROSTHESIS
K020541 · HSN
Depuy, Inc.
Orthopedic · 90d
Cleared May 20, 2002
SYNTHES PILON PLATE
K020602 · HRS
Synthes
Orthopedic · 87d
Cleared May 20, 2002
MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
K021025 · MQP
Implex Corp.
Orthopedic · 52d
Cleared May 16, 2002
MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER
K011726 · MQV
Millenium Biologix, Inc.
Orthopedic · 346d
Cleared May 16, 2002
APATIGHT-TCP BONE GRAFT SUBSTITUTE
K013966 · MQV
Cerabio, LLC
Orthopedic · 164d
Cleared May 16, 2002
APEX INTRAMEDULLARY NAIL SYSTEM
K020562 · HSB
Magly Orthopedics, LLC
Orthopedic · 85d
Cleared May 16, 2002
EBI AIS SPINE SYSTEM
K020887 · MQP
Ebi, L.P.
Orthopedic · 59d
Cleared May 16, 2002
EBI XFIX RAIL SYSTEM
K021031 · KTT
Ebi, L.P.
Orthopedic · 48d
Cleared May 14, 2002
MS-30 LATERAL FEMORAL STEM
K020713 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 70d
Cleared May 14, 2002
SL-PLUS LATERALIZED STEM
K021178 · JDI
Plus Orthopedics
Orthopedic · 29d