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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,850 results
12361–12384 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 11, 2002
RABEA CEMENT RESTRICTOR
K020836 · JDK
Signus Medical, LLC
Orthopedic · 89d
Cleared Jun 11, 2002
TOTAL HIP FEMORAL HEAD - 12/14 TAPER
K021673 · LZO
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared Jun 06, 2002
HBS HEADLESS BONE SCREW
K020791 · HWC
Millennium Medical Technologies, Inc.
Orthopedic · 87d
Cleared Jun 06, 2002
SCORPIO INSET PATELLAR COMPONENT
K020830 · JWH
Howmedica Osteonics Corp.
Orthopedic · 84d
Cleared Jun 06, 2002
OSCAR, MODEL OE3000
K021502 · LZV
Orthosonics, Ltd.
Orthopedic · 28d
Cleared Jun 05, 2002
OMEGA II SYSTEM
K020772 · KTT
Howmedica Osteonics Corp.
Orthopedic · 89d
Cleared Jun 05, 2002
REDUCED SIZE ONCOLOGY SALVAGE SYSTEM
K021260 · KRO
Biomet, Inc.
Orthopedic · 47d
Cleared Jun 05, 2002
ASCENT ALL-POLY PS TIBIAL BEARINGS
K021559 · JWH
Biomet, Inc.
Orthopedic · 23d
Cleared Jun 05, 2002
FIXED BEARING UNI COMPONENT
K021621 · HRY
Biomet, Inc.
Orthopedic · 20d
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