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
13537–13560 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 17, 1999
MAXIM REMOVABLE MOLDED POLY TIBIA
K991753 · JWH
Biomet, Inc.
Orthopedic · 85d
Cleared Aug 17, 1999
KMI WRIST FUSION SYSTEM
K991873 · HRS
Kinetikos Medical, Inc.
Orthopedic · 76d
Cleared Aug 17, 1999
EBI XFIX DFS OPTIROM ELBOW FIXATOR
K992515 · KTT
Ebi, L.P.
Orthopedic · 20d
Cleared Aug 13, 1999
ARTHREX MENISCAL DART SYSTEM
K983577 · MAI
Arthrex, Inc.
Orthopedic · 304d
Cleared Aug 13, 1999
EBI OMEGA 21 SYSTEM
K991721 · MNI
Ebi Electro Biology
Orthopedic · 85d
Cleared Aug 13, 1999
ENDOSCOPIC SPINAL ACCESS SYSTEM
K991794 · HRX
Endius, Inc.
Orthopedic · 79d
Cleared Aug 13, 1999
PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING
K992025 · MEH
Howmedica Osteonics Corp.
Orthopedic · 58d
Cleared Aug 13, 1999
OSTEONICS UNIVERSAL DISTAL CEMENT PLUG
K992462 · LZN
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Aug 12, 1999
RIWO DRIVE GENERATOR
K984304 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 253d
Cleared Aug 12, 1999
WHITESIDE BIOMECHANICS SPINAL SYSTEM
K991678 · KWQ
Whiteside Biomechanics, Inc.
Orthopedic · 87d
Cleared Aug 12, 1999
ULTIMAX HAIG II NAIL SYSTEM
K991889 · LXT
Encore Orthopedics, Inc.
Orthopedic · 70d
Cleared Aug 12, 1999
ENCORE FULLY COATED HIP
K992109 · LPH
Encore Orthopedics, Inc.
Orthopedic · 51d
Cleared Aug 12, 1999
KINEMATIC II ROTATING HINGE KNEE
K992346 · LGE
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Aug 06, 1999
HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA)...
K990666 · MEH
Smith & Nephew, Inc.
Orthopedic · 157d
Cleared Aug 06, 1999
BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE
K991715 · MAI
Linvatec Corp.
Orthopedic · 78d
Cleared Aug 06, 1999
ULTIMAX ANKLE FUSION ROD SYSTEM
K991790 · HSB
Encore Orthopedics, Inc.
Orthopedic · 72d
Cleared Aug 06, 1999
VHS SUPRACONDYLAR PLATE SYSTEM
K991806 · KTT
Walter Abendschein, M.D.
Orthopedic · 72d
Cleared Aug 06, 1999
MACMED PAEDIATRIC INTRAMEDULLARY NAIL
K991877 · JDS
Innervision, Inc.
Orthopedic · 65d
Cleared Aug 06, 1999
FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES
K992040 · HRX
Fiber Imaging Technologies, Inc.
Orthopedic · 50d
Cleared Aug 03, 1999
INTER-OP METASUL ACETABULAR SYSTEM
K974728 · KWA
Sulzer Orthopedics, Inc.
Orthopedic · 593d
Cleared Aug 03, 1999
SOLUSTAPLE
K991566 · JDR
New Deal, S.A.
Orthopedic · 90d
Cleared Jul 30, 1999
UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM
K982859 · HRY
Plus Orthopedics
Orthopedic · 351d
Cleared Jul 30, 1999
AGC V2 REVISION KNEE SYSTEM
K984054 · JWH
Biomet, Inc.
Orthopedic · 259d
Cleared Jul 30, 1999
RABEA DEVICE, MODEL PXXXXXX
K990345 · JDK
Signus Medizintechnik GmbH
Orthopedic · 176d