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
6217–6240 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 27, 2014
FLOSPINE PEDICLE SCREW SYSTEM
K141850 · NKB
Flospine
Orthopedic · 110d
Cleared Oct 27, 2014
VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL
K141407 · MBH
Biomet, Inc.
Orthopedic · 152d
Cleared Oct 27, 2014
BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)
K141331 · JDI
Biomet, Inc.
Orthopedic · 159d
Cleared Oct 24, 2014
CrossCLIP Implant System
K142727 · JDR
Orthodiscovery Group, LLC(D.B.A....
Orthopedic · 31d
Cleared Oct 24, 2014
4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm...
K142574 · MBI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 42d
Cleared Oct 24, 2014
STALIF CTI, STALIF C
K142079 · OVE
Centinel Spine, Inc.
Orthopedic · 85d
Cleared Oct 24, 2014
PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM
K141714 · HTY
Wrightmedicaltechnologyinc
Orthopedic · 121d
Cleared Oct 24, 2014
UNIVERSAL NAVIGATION INSTRUMENTS
K140927 · OLO
Medos International SARL
Orthopedic · 196d
Cleared Oct 23, 2014
ABACUS (TM) SPACER SYSTEM
K142101 · MAX
Spine Wave, Inc.
Orthopedic · 83d
Cleared Oct 22, 2014
VALOR Hindfoot Fusion Nail System
K142602 · HSB
Wrightmedicaltechnologyinc
Orthopedic · 37d
Cleared Oct 22, 2014
Zimmer Periarticular Plating System
K142579 · HRS
Zimmer, Inc.
Orthopedic · 37d
Cleared Oct 22, 2014
ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM
K142281 · HSB
Zimmer, Inc.
Orthopedic · 68d
Cleared Oct 21, 2014
Xia 3 Spinal System
K142381 · NKB
Stryker Corp.
Orthopedic · 56d
Cleared Oct 21, 2014
CD HORIZON SPINAL SYSTEM
K141604 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 127d
Cleared Oct 20, 2014
SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
K142026 · ODP
Spinefrontier, Inc.
Orthopedic · 87d
Cleared Oct 20, 2014
AILERON INTERSPINOUS FIXATION SYSTEM
K140236 · PEK
Life Spine, Inc.
Orthopedic · 263d
Cleared Oct 17, 2014
Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS,...
K142589 · MAX
Titan Spine, LLC
Orthopedic · 32d
Cleared Oct 17, 2014
NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT
K141600 · MQV
Pioneer Surgical Technology, Inc....
Orthopedic · 123d
Cleared Oct 16, 2014
G-Lok and G-Lok XL Extender
K142653 · MBI
T.A.G. Medical Products Corporation,...
Orthopedic · 28d
Cleared Oct 15, 2014
COGENT MED-LIF XL
K142193 · MAX
Cogent Spine, LLC
Orthopedic · 65d
Cleared Oct 15, 2014
RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
K142095 · OVD
Renovis Surgical Technologies, Inc.
Orthopedic · 75d
Cleared Oct 14, 2014
JULIET PO
K142277 · MAX
Spineart
Orthopedic · 60d
Cleared Oct 10, 2014
FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM
K141106 · OUR
Folsom Metal Products, Inc. Dba...
Orthopedic · 164d
Cleared Oct 10, 2014
INTEGRA EXTERNAL FIXATION SYSTEM
K140463 · KTT
Ascension Orthopedic
Orthopedic · 228d