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
7969–7992 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 21, 2011
ENSPIRE DEBRIDER SYSTEM
K110992 · HRX
Spine View, Inc.
Orthopedic · 196d
Cleared Oct 21, 2011
CD HORIZON SPINAL SYSTEM
K112473 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 56d
Cleared Oct 20, 2011
SYNTHES XRL
K103320 · MQP
Synthes Spine Co.Lp
Orthopedic · 342d
Cleared Oct 20, 2011
XTRAFIX EXTERNAL FIXATION SYSTEM
K111155 · KTT
Extraortho, Inc.
Orthopedic · 178d
Cleared Oct 20, 2011
TIGER HEADLESS CANNULATED SCREWS
K112737 · HWC
Trilliant Surgical, Ltd.
Orthopedic · 30d
Cleared Oct 18, 2011
DASH HIP
K110021 · OLO
Brainlab AG
Orthopedic · 288d
Cleared Oct 18, 2011
SMARTLOC SPINAL FIXATION SYSTEM
K111883 · MNI
A-Spine Asia, Co., Ltd.
Orthopedic · 109d
Cleared Oct 18, 2011
APCLO PEDICLE SCREW SYSTEMS
K112759 · NKB
Atlas Spine, Inc.
Orthopedic · 26d
Cleared Oct 17, 2011
PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES
K103598 · MBH
Wrightmedicaltechnologyinc
Orthopedic · 313d
Cleared Oct 17, 2011
GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF)
K111354 · MAX
GS Medical Co., Ltd.
Orthopedic · 157d
Cleared Oct 17, 2011
ZYSTON STRAIGHT SPACER SYSTEM
K112014 · MAX
Biomet Spine
Orthopedic · 95d
Cleared Oct 14, 2011
POLARCUP DUAL MOBILITY SYSTEM
K110135 · LPH
Smith & Nephew, Inc.
Orthopedic · 269d
Cleared Oct 14, 2011
GLADIATOR HIP STEM
K111910 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 101d
Cleared Oct 14, 2011
NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT
K112773 · MQV
Novabone Products, LLC
Orthopedic · 21d
Cleared Oct 13, 2011
MTF NEW BONE VOID FILLER
K110003 · MQV
Musculoskeletal Transplant Foundation
Orthopedic · 283d
Cleared Oct 13, 2011
ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT...
K111492 · JWH
Materialise NV
Orthopedic · 135d
Cleared Oct 12, 2011
SFC VERTEBRAL BODY REPLACEMENT
K110153 · MQP
Konigsee Implantate GmbH
Orthopedic · 266d
Cleared Oct 12, 2011
CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM
K111264 · ODP
Medtronic Sofamor Danek USA
Orthopedic · 161d
Cleared Oct 12, 2011
BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP
K112019 · KWY
Corentec Co., Ltd.
Orthopedic · 90d
Cleared Oct 11, 2011
CONCORDE BULLET SPINAL SYSTEM
K110694 · MAX
Johnson & Johnson
Orthopedic · 211d
Cleared Oct 11, 2011
SMITH & NEPHEW CANNULATED SCREWS AND WASHERS
K111994 · HWC
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Oct 11, 2011
APEX KIRSCHNER WIRES AND STEINMANN PINS
K112254 · HTY
Apex Tools & Orthopedics Co.
Orthopedic · 67d
Cleared Oct 11, 2011
AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
K112615 · PHX
Tornier, Inc.
Orthopedic · 33d
Cleared Oct 07, 2011
CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY
K110836 · KWA
Zimmer GmbH
Orthopedic · 196d