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
6697–6720 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 08, 2014
EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM
K133452 · HRS
Emerge Medical
Orthopedic · 57d
Cleared Jan 07, 2014
D-RAD SMART PACK
K132296 · HRS
Smith & Nephew, Inc.
Orthopedic · 168d
Cleared Jan 07, 2014
AXIA RADIAL HEAD SYSTEM
K132735 · KWI
Imds (Innovative MEdical Device...
Orthopedic · 126d
Cleared Jan 06, 2014
LATERAL SYNFIX
K131276 · OVD
Synthes USA Products, LLC
Orthopedic · 245d
Cleared Jan 06, 2014
ACUMED HAND PLATING SYSTEM
K132769 · HRS
Acumed, LLC
Orthopedic · 124d
Cleared Jan 06, 2014
DISTALOCK TIBIAL IM NAIL SYSTEM
K132830 · HSB
Dgimed Ortho, Inc.
Orthopedic · 118d
Cleared Jan 03, 2014
SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM
K131880 · OVE
Spinefrontier, Inc.
Orthopedic · 192d
Cleared Jan 03, 2014
ORTHOHELIX SYNDESMOSIS FIXATION DEVICES
K132733 · HTN
Orthohelix Surgical Designs, Inc.
Orthopedic · 122d
Cleared Jan 03, 2014
Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2...
K133224 · MBI
Conmed Corporation
Orthopedic · 74d
Cleared Jan 03, 2014
PERIMETER C SPINAL SYSTEM, CAPSTONE SPINAL SYSTEM, CAPSTONE L SPINAL SYSTEM,...
K133645 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 37d
Cleared Dec 31, 2013
TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS,...
K133081 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 92d
Cleared Dec 30, 2013
MONUMENT SPACERS
K132559 · OVD
Globus Medical, Inc.
Orthopedic · 137d
Cleared Dec 30, 2013
SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR...
K132867 · MBI
Cayenne Medical, Inc.
Orthopedic · 108d
Cleared Dec 30, 2013
COMPRESSYN STAPLE
K132875 · JDR
Dallen Medical, Inc.
Orthopedic · 108d
Cleared Dec 27, 2013
REUNION RSA SHOULDER SYSTEM
K130895 · PHX
Howmedica Osteonics Corp.
Orthopedic · 270d
Cleared Dec 24, 2013
SIGNIFY BIOACTIVE
K130977 · MQV
Globus Medical, Inc.
Orthopedic · 259d
Cleared Dec 24, 2013
VELOX ANTERIOR CERVICAL PLATE SYSTEM
K131521 · KWQ
Spinecraft, LLC
Orthopedic · 210d
Cleared Dec 24, 2013
PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE
K131724 · MQP
Pioneer Surgical Technology, Inc.
Orthopedic · 195d
Cleared Dec 24, 2013
COROENT STERILE IMPLANTS SYSTEM
K132601 · MAX
Nu Vasive, Incorporated
Orthopedic · 126d
Cleared Dec 24, 2013
LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE
K132787 · HRS
Aap Implantate AG
Orthopedic · 109d
Cleared Dec 23, 2013
ASCOT
K132310 · KWQ
Backroads Consulting, Inc.
Orthopedic · 151d
Cleared Dec 20, 2013
IDEAL
K132428 · HSB
Jiangsu Ideal Medical Science &...
Orthopedic · 137d
Cleared Dec 20, 2013
INFIX ANTERIOR LUMBAR SYSTEM
K132790 · MAX
Zimmer Spine, Inc.
Orthopedic · 105d
Cleared Dec 20, 2013
AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM
K133052 · PEK
Nuvasive, Inc.
Orthopedic · 84d