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
12097–12120 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 11, 2003
PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS
K031495 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 29d
Cleared Jun 10, 2003
WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS...
K030519 · JEC
Hand Biomechanics Lab, Inc.
Orthopedic · 111d
Cleared Jun 09, 2003
SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM
K031609 · HRS
Swiss Orthopedic Solutions, Inc.
Orthopedic · 18d
Cleared Jun 06, 2003
MSD CABLE REDUCTION SYSTEM
K030816 · KWP
Medtronic Sofamor Danek
Orthopedic · 84d
Cleared Jun 06, 2003
PLUS ORTHOPEDICS CEMENTED HIP STEM
K031165 · JDI
Plus Orthopedics
Orthopedic · 53d
Cleared Jun 06, 2003
CUFFLOK ANCHOR
K031519 · MAI
Mitek Worldwide
Orthopedic · 22d
Cleared Jun 06, 2003
SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE
K031573 · KTT
Synthes (Usa)
Orthopedic · 17d
Cleared Jun 04, 2003
BIO-MODULAR SHOULDER SYSTEM
K030710 · KWT
Biomet, Inc.
Orthopedic · 90d
Cleared Jun 03, 2003
ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM
K030724 · LZO
Zimmer, Inc.
Orthopedic · 88d
Cleared Jun 02, 2003
PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
K030848 · HWC
Karl Storz Endoscopy
Orthopedic · 77d
Cleared May 30, 2003
INION OTPS BIODEGRADABLE MINI PLATING SYSTEM
K023887 · HWC
Inion , Ltd.
Orthopedic · 190d
Cleared May 30, 2003
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)
K030972 · KWL
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 63d
Cleared May 30, 2003
EXOJET TISSUE MANAGEMENT SYSTEM
K031406 · HRX
Mitek Worldwide
Orthopedic · 25d
Cleared May 30, 2003
SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM
K031508 · JDQ
Synthes (Usa)
Orthopedic · 16d
Cleared May 28, 2003
ENCORE ANTERIOR SPINAL STAPLE SYSTEM
K030667 · KWQ
Encore Medical, L.P.
Orthopedic · 86d
Cleared May 28, 2003
MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
K031219 · HSB
Orthofix, Inc.
Orthopedic · 41d
Cleared May 27, 2003
GENESIS II TOTAL KNEE SYSTEM
K030612 · MBH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared May 23, 2003
GMRS PRESS FIT STEMS WITH PUREFIX HA
K031217 · LZO
Howmedica Osteonics
Orthopedic · 36d
Cleared May 22, 2003
HLS UNI EVOLUTION PROSTHESIS
K022211 · HSX
Tornier
Orthopedic · 318d
Cleared May 22, 2003
SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM
K030623 · MBH
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared May 22, 2003
APEX MODULAR ACETABULAR CUP
K031110 · LPH
Apex Surgical, LLC
Orthopedic · 44d
Cleared May 22, 2003
TEXAS T - PLATE
K031334 · HRS
Biomet, Inc.
Orthopedic · 24d
Cleared May 22, 2003
CEMEX SYSTEM FAST
K031430 · LOD
Exactech, Inc.
Orthopedic · 16d
Cleared May 20, 2003
OSSATURA BCP BONE VOID FILLER
K030131 · MQV
Isotis NV
Orthopedic · 126d