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
11617–11640 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 15, 2004
SMALL BONE FIXATION SYSTEM
K033406 · HTY
Hand Innovations, Inc.
Orthopedic · 83d
Cleared Jan 15, 2004
ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM
K033639 · HWC
Acumed, LLC
Orthopedic · 56d
Cleared Jan 15, 2004
ADVANCE DOUBLE HIGH INSERT
K033890 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared Jan 15, 2004
ARTHOSCOPY PUMP A115
K033927 · HRX
W.O.M. World of Medicine AG
Orthopedic · 28d
Cleared Jan 15, 2004
GAMMA3 NAIL SYSTEM
K034002 · HSB
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Jan 13, 2004
THE ANSWER SCREW SUPPLEMENTATION SYSTEM
K032966 · HWC
Simplicity Orthopedic Solutions, LLC
Orthopedic · 112d
Cleared Jan 13, 2004
MODIFICATION TO JET-X HA COATED HALF PINS
K033289 · JDW
Smith & Nephew, Inc.
Orthopedic · 91d
Cleared Jan 13, 2004
EBI TOP LOADING MAS SPINAL FIXATION SYSTEM
K033312 · NKB
Ebi, L.P.
Orthopedic · 91d
Cleared Jan 13, 2004
SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM
K033556 · KTT
Synthes (Usa)
Orthopedic · 62d
Cleared Jan 12, 2004
ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM
K033286 · HSB
Orthopedic Designs, Inc. (Odi)
Orthopedic · 90d
Cleared Jan 08, 2004
NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS
K031962 · JWH
Implex Corp.
Orthopedic · 197d
Cleared Jan 08, 2004
PROMOS SHOULDER
K032126 · HSD
Plus Orthopedics
Orthopedic · 182d
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