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
7801–7824 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 26, 2012
PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM
K113218 · NQW
Pioneer Surgical Technology, Inc.
Orthopedic · 86d
Cleared Jan 26, 2012
RISE SPACER
K113447 · MAX
Globus Medical, Inc.
Orthopedic · 66d
Cleared Jan 25, 2012
XENON(TM) PEDICLE SCREW SYSTEM
K111634 · NKB
Alphatec Spine, Inc.
Orthopedic · 226d
Cleared Jan 25, 2012
CARDIFF ANTERIOR CERVICAL PLATE SYSTEM
K112206 · KWQ
Seaspine, Inc.
Orthopedic · 177d
Cleared Jan 24, 2012
IVAS BALLOON CATHETER
K113154 · NDN
Stryker Corporation
Orthopedic · 90d
Cleared Jan 24, 2012
MTF NEW BONE VOILD FILLER
K113167 · MQV
Musculoskeletal Transplant Foundation
Orthopedic · 89d
Cleared Jan 23, 2012
SYNDE-LOCK SYNDESMOSIS REPAIR KIT
K111971 · HWC
Tarsus Medical, Inc.
Orthopedic · 196d
Cleared Jan 20, 2012
RELIANCE SPINAL SCREW SYSTEM
K110896 · MNI
Reliance Medical Systems, LLC
Orthopedic · 296d
Cleared Jan 20, 2012
SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR
K113294 · MBI
Smith & Nephew, Inc.
Orthopedic · 73d
Cleared Jan 20, 2012
LEXUS ANTERIOR CERVICAL PLATE SYSTEM
K113509 · KWQ
L & K Biomed Co., Ltd.
Orthopedic · 53d
Cleared Jan 20, 2012
OPTICAGE INTERBODY FUSION DEVICE
K113527 · MAX
Interventional Spine, Inc.
Orthopedic · 51d
Cleared Jan 19, 2012
OASYS SPINAL SYSTEM
K111719 · KWP
Stryker Spine
Orthopedic · 213d
Cleared Jan 19, 2012
NANOVIS SPINAL SYSTEM
K113173 · NKB
Nanovis, LLC
Orthopedic · 84d
Cleared Jan 17, 2012
CUFFINK
K112814 · MBI
Cayenne Medical, Inc.
Orthopedic · 112d
Cleared Jan 17, 2012
PEEK PREVAIL CERVICAL INTERBODY DEVICE
K113252 · OVE
Medtronic Sofamor Danek
Orthopedic · 75d
Cleared Jan 17, 2012
K2M, PYRENEES CERVICAL PLATE SYSTEM
K113329 · KWQ
K2m, Inc.
Orthopedic · 64d
Cleared Jan 17, 2012
LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM
K113366 · NKB
Phygen, LLC
Orthopedic · 63d
Cleared Jan 17, 2012
PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF...
K113730 · MBI
Parcus Medical, LLC
Orthopedic · 29d
Cleared Jan 13, 2012
VARIOUS
K112417 · MBI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 143d
Cleared Jan 13, 2012
MEDICAL FACETS CORICAL SCREWS, MEDICAL FACETS CANCELLOUS SCREWS, MEDICAL...
K112727 · HWC
Medical Facets
Orthopedic · 115d
Cleared Jan 12, 2012
OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM
K113123 · KTT
The Orthopaedic Implant Company
Orthopedic · 83d
Cleared Jan 12, 2012
ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM
K113318 · HRS
Acute Innovations, LLC
Orthopedic · 63d
Cleared Jan 12, 2012
CASPIAN
K113654 · KWP
K2m, Inc.
Orthopedic · 31d
Cleared Jan 11, 2012
COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY
K113069 · PHX
Biomet Manufacturing Corp
Orthopedic · 86d