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
11713–11736 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 08, 2004
PINNACLE REVISION SYSTEM
K033338 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 83d
Cleared Jan 08, 2004
STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM
K033837 · MQP
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Dec 31, 2003
KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS)
K033242 · HSH
Imaging Therapeutics, Inc.
Orthopedic · 85d
Cleared Dec 31, 2003
BIOANCHOR WITH DISPOSABLE DRIVER
K033804 · HWC
Linvatec Corp.
Orthopedic · 23d
Cleared Dec 23, 2003
SUBTALAR PEG IMPLANT
K033046 · MJW
Nexa Orthopedics, Inc.
Orthopedic · 85d
Cleared Dec 22, 2003
FIDJI SMALL CEMENT RESTRICTOR
K030767 · JDK
Spine Next SA
Orthopedic · 286d
Cleared Dec 22, 2003
FIDJI LARGE CEMENT RESTRICTOR
K030871 · JDK
Spine Next SA
Orthopedic · 278d
Cleared Dec 19, 2003
REVOLUTION SPINAL FIXATION SYSTEM
K032219 · MNI
Spinal Innovations, Inc.
Orthopedic · 151d
Cleared Dec 19, 2003
VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL
K032288 · MQV
Orthovita, Inc.
Orthopedic · 148d
Cleared Dec 19, 2003
GEM INSET PATELLAR COMPONENT
K032950 · JWH
Kinamed, Inc.
Orthopedic · 88d
Cleared Dec 19, 2003
DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM
K033280 · JDC
Biomet, Inc.
Orthopedic · 70d
Cleared Dec 18, 2003
COMPRESS DISTAL FEMORAL REPLACEMENT
K031804 · KRO
Biomet, Inc.
Orthopedic · 190d
Cleared Dec 18, 2003
MODIFICATION TO SLIM GLIDING NAIL SYSTEM
K033763 · KTT
Plus Orthopedics
Orthopedic · 16d
Cleared Dec 17, 2003
PALACOS R BONE CEMENT WITH GENTAMICIN
K030086 · LOD
Biomet, Inc.
Orthopedic · 342d
Cleared Dec 17, 2003
B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM)
K032358 · HRX
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 140d
Cleared Dec 17, 2003
MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM
K033664 · LZO
Centerpulse Orthopedics, Inc.
Orthopedic · 26d
Cleared Dec 15, 2003
AEQUALIS SHOULDER FRACTURE SYSTEM
K032679 · KWS
Tornier
Orthopedic · 108d
Cleared Dec 15, 2003
SUBTALAR ARTHRORISIS IMPLANT
K032902 · HWC
Nexa Orthopedics, Inc.
Orthopedic · 89d
Cleared Dec 15, 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K033322 · MNH
Medtronic Sofamor Danek
Orthopedic · 61d
Cleared Dec 15, 2003
LORENZ STERNAL CLOSURE SYSTEM
K033740 · HWC
Walter Lorenz Surgical, Inc.
Orthopedic · 17d
Cleared Dec 12, 2003
VERTELINK KOBRA SPINAL FIXATION SYSTEM
K032102 · KWQ
Vertelink Corporation
Orthopedic · 157d
Cleared Dec 11, 2003
MBCP
K032268 · MQV
Biomatlante
Orthopedic · 141d
Cleared Dec 10, 2003
SCORPIO LOW PROFILE TIBIAL TRAY
K032829 · JWH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Dec 10, 2003
STRYKER SPINE MAPS SYSTEM
K032855 · MNH
Howmedica Osteonics
Orthopedic · 89d