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
9313–9336 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 16, 2008
TOGGLELOC SYSTEM
K083070 · MBI
Biomet Sports Medicine
Orthopedic · 62d
Cleared Dec 15, 2008
VISIONSENSE STEREOSCOPIC VISION SYSTEM
K082355 · HRX
Visionsense, Ltd.
Orthopedic · 122d
Cleared Dec 15, 2008
EOS SPINAL SYSTEM
K082509 · MNH
Korea Bone Bank Co., Ltd.
Orthopedic · 108d
Cleared Dec 15, 2008
BIOPRO BIPOLAR HEAD, MODELS 18130-18152
K082705 · KWY
Biopro, Inc.
Orthopedic · 90d
Cleared Dec 12, 2008
CONSERVE PRESSFIT FEMORAL COMPONENT
K082673 · KXA
Wrightmedicaltechnologyinc
Orthopedic · 88d
Cleared Dec 12, 2008
SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT
K082795 · MRW
Interventional Spine, Inc.
Orthopedic · 80d
Cleared Dec 11, 2008
MESA AND RANGE SPINAL SYSTEMS
K082769 · KWP
K2m, Inc.
Orthopedic · 80d
Cleared Dec 11, 2008
ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL
K082770 · HSB
Zimmer, Inc.
Orthopedic · 80d
Cleared Dec 11, 2008
CLAMPFIX
K082914 · NKB
Synthes Spine
Orthopedic · 72d
Cleared Dec 11, 2008
CAPSURE(R) PS SYSTEM
K083353 · MNI
Spine Wave, Inc.
Orthopedic · 28d
Cleared Dec 11, 2008
2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM...
K083364 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Dec 10, 2008
PASS LP SPINAL SYSTEM
K083308 · MNI
Medicrea Technologies
Orthopedic · 30d
Cleared Dec 09, 2008
NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
K082672 · MQV
Novabone Products, LLC
Orthopedic · 85d
Cleared Dec 08, 2008
HAV-LOK BUNION CORRECTION SYSTEM
K082384 · HTN
Instratek, Inc.
Orthopedic · 111d
Cleared Dec 08, 2008
MAXTORQUE MINI CANNULATED SCREW SYSTEM
K082574 · HWC
Orthohelix Surgical Designs, Inc.
Orthopedic · 94d
Cleared Dec 04, 2008
ALLOFUSE GEL AND PUTTY
K071849 · MQV
Allosource, Inc.
Orthopedic · 518d
Cleared Dec 04, 2008
MICROWARE BONE PLATES AND BONE SCREWS
K072562 · HRS
Microware Precision Co., Ltd.
Orthopedic · 450d
Cleared Dec 04, 2008
DEPUY ASPHERE M-SPEC HEAD
K082585 · KWA
DePuy Orthopaedics, Inc.
Orthopedic · 87d
Cleared Dec 03, 2008
MERCURY SPINAL SYSTEM
K083230 · NKB
Spinal Elements, Inc.
Orthopedic · 30d
Cleared Nov 28, 2008
DDS STABILIZATION SYSTEM
K080241 · NQP
Paradigm Spine, LLC
Orthopedic · 302d
Cleared Nov 28, 2008
MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM
K082172 · HSX
Mako Surgical Corporation
Orthopedic · 119d
Cleared Nov 26, 2008
SI JOINT FUSION SYSTEM
K080398 · OUR
SI-BONE, Inc.
Orthopedic · 287d
Cleared Nov 25, 2008
POGO SCREW
K080649 · HWC
Fxdevices
Orthopedic · 263d
Cleared Nov 25, 2008
SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY
K082358 · JWH
Smith & Nephew, Inc.
Orthopedic · 99d