FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,766 results
11641–11664 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Dec 10, 2003
SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)
K033669 · HRS
Smith & Nephew, Inc.
Orthopedic · 19d
Cleared Dec 08, 2003
ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT
K032812 · MQP
Orthovita, Inc.
Orthopedic · 90d
Cleared Dec 05, 2003
CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET
K033519 · HRS
Biomet, Inc.
Orthopedic · 28d
Cleared Dec 04, 2003
DEPUY ASR RESURFACING FEMORAL HEADS
K032659 · KXA
DePuy Orthopaedics, Inc.
Orthopedic · 98d
Cleared Dec 03, 2003
Z-SERIES MODULAR TOTAL HIP SYSTEM
K032729 · LPH
Osteoimplant Technology, Inc.
Orthopedic · 91d
Cleared Dec 03, 2003
R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM
K032752 · KWQ
R&B Surgical Solutions, LLC
Orthopedic · 89d
Cleared Dec 03, 2003
MODIFICATION TO EQUATION FIXATION SYSTEM
K033495 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Dec 03, 2003
MODIFICATION TO TELEGRAPH HUMERAL NAIL
K033510 · HSB
Fournitures Hospitalieres Industrie
Orthopedic · 27d
Cleared Dec 03, 2003
DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS
K033516 · HSD
DePuy Orthopaedics, Inc.
Orthopedic · 26d
Cleared Dec 03, 2003
TIE-IN TRAPEZIUM
K033529 · KYI
Wrightmedicaltechnologyinc
Orthopedic · 23d
Cleared Dec 03, 2003
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K033635 · KTT
Ebi, L.P.
Orthopedic · 14d
Cleared Dec 02, 2003
CAP3 BONE SUBSTITUTE MATERIAL
K033138 · MQV
Etex Corp.
Orthopedic · 63d