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
7849–7872 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 21, 2011
RANGE SPINAL SYSTEM (MESA AND DENALI)
K112920 · MNI
K2m, Inc.
Orthopedic · 79d
Cleared Dec 21, 2011
SYNTHES MIRS
K113044 · NKB
Synthes Spine
Orthopedic · 70d
Cleared Dec 20, 2011
LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL...
K112941 · JWH
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Dec 20, 2011
MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS
K113028 · HRX
Medisiss
Orthopedic · 70d
Cleared Dec 20, 2011
IFS SUBTALAR IMPLANT
K113399 · HWC
Internal Fixation Systems, Inc.
Orthopedic · 33d
Cleared Dec 20, 2011
LIMACORPORATE SMR REVERSE SHOULDER SYSTEM
K113523 · PHX
Lima Corporate S.P.A.
Orthopedic · 21d
Cleared Dec 20, 2011
CLYDESDALE(R) SPINAL SYSTEM
K113528 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 20d
Cleared Dec 20, 2011
HEALIX KNOTLESS ANCHOR
K113534 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 20d
Cleared Dec 19, 2011
ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS
K110895 · HWC
Ortho Solutions Limited
Orthopedic · 264d
Cleared Dec 19, 2011
MECTA-C
K112862 · ODP
Medacta International
Orthopedic · 80d
Cleared Dec 19, 2011
ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY
K112885 · HWC
Zimmer, Inc.
Orthopedic · 80d
Cleared Dec 19, 2011
AXSOS LOCKING PLATE SYSTEM
K112926 · HRS
Stryker Corp.
Orthopedic · 77d
Cleared Dec 19, 2011
ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE
K112990 · HTY
Arthrex, Inc.
Orthopedic · 74d
Cleared Dec 19, 2011
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
K113434 · NKB
Lanx, Inc.
Orthopedic · 28d
Cleared Dec 16, 2011
PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES
K110360 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 311d
Cleared Dec 16, 2011
LANX CERVICAL SA
K112388 · OVE
Lanx, Inc.
Orthopedic · 120d
Cleared Dec 16, 2011
RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW
K112819 · HRS
Xiamen Double Engline Medical...
Orthopedic · 79d
Cleared Dec 16, 2011
COMPREHENSIVE REVERSE SHOULDER
K113121 · PHX
Biomet Manufacturing, Inc.
Orthopedic · 56d
Cleared Dec 16, 2011
INSTINCT JAVA SYSTEM
K113270 · NKB
Zimmer Spine
Orthopedic · 42d
Cleared Dec 15, 2011
LANCER PEDICLE SCREW SYSTEM
K110633 · MNH
Spinal Solutions, LLC
Orthopedic · 286d
Cleared Dec 15, 2011
COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS)
K111746 · KWT
Biomet, Inc.
Orthopedic · 177d
Cleared Dec 15, 2011
ARTHREX BIOCOMPOSITE TRANSFIX
K112040 · MAI
Arthrex, Inc.
Orthopedic · 150d
Cleared Dec 15, 2011
ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS
K112218 · KTT
DePuy Orthopaedics, Inc.
Orthopedic · 135d
Cleared Dec 15, 2011
APTUS(R) DISTAL HUMERUS SYSTEM
K112560 · HRS
Medartis AG
Orthopedic · 104d