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
6841–6864 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 10, 2013
POLARUS CONNECT
K131636 · LXT
Acumed, LLC
Orthopedic · 128d
Cleared Oct 10, 2013
BIOLOX(R) DELTA CERAMIC HEADS
K131684 · LZO
Biomet, Inc.
Orthopedic · 122d
Cleared Oct 10, 2013
IMPLANET SPINE SYSTEM
K132303 · OSH
Implanet, S.A.
Orthopedic · 78d
Cleared Oct 10, 2013
INERTIA MIS PEDICLE SCREW SYSTEM
K132412 · MNI
Nexxt Spine, LLC
Orthopedic · 69d
Cleared Oct 09, 2013
COMPREHENSIVE CONVERTIBLE GLENOID
K130390 · PHX
Biomet Manufacturing, Inc.
Orthopedic · 236d
Cleared Oct 09, 2013
CEZANNE II INTERBODY FUSION SYSTEM
K131981 · MAX
Accel Spine
Orthopedic · 103d
Cleared Oct 09, 2013
DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW
K132704 · LXT
Biomet
Orthopedic · 41d
Cleared Oct 08, 2013
SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM
K131186 · HRS
Synthes USA Products, LLC
Orthopedic · 166d
Cleared Oct 08, 2013
COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE
K131353 · PHX
Biomet Manufacturing Corp
Orthopedic · 151d
Cleared Oct 08, 2013
APEX KNEE MODULAR TIBIA SYSTEM
K131472 · JWH
Omni Life Science, Inc.
Orthopedic · 139d
Cleared Oct 08, 2013
CD HORIZON SPINAL SYSTEM
K132471 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 62d
Cleared Oct 08, 2013
ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO)
K132589 · KWQ
Life Spine, Inc.
Orthopedic · 50d
Cleared Oct 07, 2013
TRELLIS COLLAGEN RIBBON
K131143 · OWY
Wrightmedicaltechnologyinc
Orthopedic · 167d
Cleared Oct 07, 2013
CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM
K131769 · MBI
Pivot Medical, Inc.
Orthopedic · 112d
Cleared Oct 04, 2013
AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G,...
K131820 · HRX
Care Fusion
Orthopedic · 106d
Cleared Oct 04, 2013
STAXX IBL SYSTEM
K132719 · MAX
Spine Wave, Inc.
Orthopedic · 35d
Cleared Oct 03, 2013
NEO KNEE SYSTEM
K131368 · JWH
Pipeline Orthopedics
Orthopedic · 143d
Cleared Oct 03, 2013
MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT
K131673 · MQV
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 118d
Cleared Oct 03, 2013
AVAFLEX VERTEBRAL BALLOON SYSTEM
K131824 · HRX
Care Fusion
Orthopedic · 105d
Cleared Oct 03, 2013
EVEREST SPINAL SYSTEM
K132361 · MNI
K2m, Inc.
Orthopedic · 65d
Cleared Oct 03, 2013
AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5
K132554 · HRS
Aap Implantate AG
Orthopedic · 50d
Cleared Oct 03, 2013
PASS LP SPINAL SYSTEM
K132575 · OSH
Medicrea International
Orthopedic · 48d
Cleared Oct 03, 2013
LOCKING PLATE SYSTEM
K132642 · HRS
Beijing Libeier Bio-Engineering...
Orthopedic · 38d
Cleared Oct 03, 2013
NAUTILUS SPINAL SYSTEM
K132760 · NKB
Life Spine, Inc.
Orthopedic · 29d