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
6049–6072 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 26, 2015
VERTA Corpectomy Cage
K143490 · MQP
Camber Spine
Orthopedic · 49d
Cleared Jan 26, 2015
AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK...
K143163 · OVD
Stryker Corporation
Orthopedic · 84d
Cleared Jan 26, 2015
Activ Ankle Locking Plating System
K143061 · HRS
Newclip Technics
Orthopedic · 94d
Cleared Jan 26, 2015
CB PROT II Posterior Spinal System
K142655 · MNH
Chin Bone Technique Corp
Orthopedic · 130d
Cleared Jan 26, 2015
Trident® Tritanium® PST® Acetabular Shells
K142606 · LPH
Mako Surgical Corp.
Orthopedic · 133d
Cleared Jan 26, 2015
Aviator Anterior Cervical Plate (ACP) System
K142237 · KWQ
Stryker Corporation
Orthopedic · 166d
Cleared Jan 26, 2015
OMNI Interface Acetabular System
K142201 · LPH
Omnlife Science
Orthopedic · 168d
Cleared Jan 26, 2015
LEVA (TM) SPACER SYSTEM
K141980 · MAX
Spine Wave, Inc.
Orthopedic · 189d
Cleared Jan 23, 2015
Cannulated Screw System
K143460 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 50d
Cleared Jan 23, 2015
Acumed Small Fragment Base Set
K143394 · HRS
Acumed, LLC
Orthopedic · 58d
Cleared Jan 23, 2015
Quattro Bolt Tenodesis Screw
K143392 · MBI
Cayenne Medical, Inc.
Orthopedic · 58d
Cleared Jan 23, 2015
STGC-LORDOTIC
K142030 · MQP
Cardinal Spine, LLC
Orthopedic · 182d
Cleared Jan 23, 2015
STIMULAN KIT, STIMULAN RAPID CURE
K141830 · MQV
Biocomposites, Ltd.
Orthopedic · 200d
Cleared Jan 22, 2015
Sonoma Fibula Repair System
K142945 · HSB
Sonoma Orthopedic Products, Inc.
Orthopedic · 104d
Cleared Jan 22, 2015
EXCERA FITRITE TOTAL HIP ARTHROPLASTY SYSTEM
K140547 · LPH
Excera Orthopedics, Inc.
Orthopedic · 324d
Cleared Jan 21, 2015
ADVANCE Porous Coated Spiked Tibial Base
K143366 · MBH
Microport Orthopedics, Inc.
Orthopedic · 58d
Cleared Jan 21, 2015
NuVasive ALIF Buttress Plate System
K143065 · KWQ
Nu Vasive, Incorporated
Orthopedic · 89d
Cleared Jan 21, 2015
Everest Spinal System
K142360 · NKB
K2m, Inc.
Orthopedic · 149d
Cleared Jan 21, 2015
NANOFUSE DBM
K142104 · MQV
Nanotherapeutics, Inc.
Orthopedic · 173d
Cleared Jan 21, 2015
DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM
K141599 · OVE
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 222d
Cleared Jan 20, 2015
SnapShot Fixation System
K143037 · JDR
Biomet Manufacturing Corp
Orthopedic · 90d
Cleared Jan 20, 2015
Synapse Occipital-Cervical-Thoracic (OCT) System
K142838 · NKG
Synthes USA Products, LLC
Orthopedic · 112d
Cleared Jan 20, 2015
PATIENT SPECIFIC DISTAL FEMORAL
K140898 · KRO
Stanmore Implants Worldwide , Ltd.
Orthopedic · 287d
Cleared Jan 16, 2015
Arthrex Low Profile Screws
K143614 · HWC
Arthrex, Inc.
Orthopedic · 28d