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
8377–8400 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 13, 2011
CASPIAN SPINAL SYSTEM
K103232 · KWP
K2m, Inc.
Orthopedic · 72d
Cleared Jan 12, 2011
ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR
K102121 · OVD
Apollo Spine, Inc.
Orthopedic · 167d
Cleared Jan 12, 2011
ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER)
K102834 · JDQ
Kinamed, Incorporated
Orthopedic · 105d
Cleared Jan 12, 2011
GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM +
K103070 · KWQ
G Surgical Co., Ltd.
Orthopedic · 86d
Cleared Jan 10, 2011
TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX
K103033 · ODP
Zimmer Trabecular Metal Technology
Orthopedic · 89d
Cleared Jan 10, 2011
ALLOFUSE PLUS
K103036 · MQV
Allosource, Inc.
Orthopedic · 89d
Cleared Jan 10, 2011
AVAMAX VERTEBRAL BALLOON
K103064 · NDN
Care Fusion
Orthopedic · 84d
Cleared Jan 07, 2011
ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL
K101588 · OVE
Apollo Spine, Inc.
Orthopedic · 214d
Cleared Jan 07, 2011
ARTHREX SWIVELOCK ANCHORS
K101823 · MAI
Arthrex, Inc.
Orthopedic · 191d
Cleared Jan 07, 2011
TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND...
K102298 · HWC
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 147d
Cleared Jan 07, 2011
STINGRAY CERVICAL CAGE
K102322 · MAX
Omni Surgical, L.P.
Orthopedic · 143d
Cleared Jan 07, 2011
EVOLUTION MP TOTAL KNEE SYSTEM
K102380 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 137d
Cleared Jan 07, 2011
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K103117 · JWH
Conformis, Inc.
Orthopedic · 78d
Cleared Jan 06, 2011
THE GRAPPLR AND GRAPPLR EXTENDER
K101616 · MBI
Tag Medical Corp.
Orthopedic · 211d
Cleared Jan 05, 2011
MULTIFIT TOTAL HIP SYSTEM
K101472 · LZO
Otis Biotech Co., Ltd.
Orthopedic · 223d
Cleared Jan 05, 2011
CALIBER SPACER
K102293 · MAX
Globus Medical, Inc.
Orthopedic · 145d
Cleared Jan 05, 2011
ENDOBUTTON DIRECT
K102982 · MAI
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 90d
Cleared Jan 05, 2011
ARTHREX TIBIAL GRAFTBOLT
K103060 · MBI
Arthrex, Inc.
Orthopedic · 79d
Cleared Jan 05, 2011
PARAMOUNT R IBF DEVICE
K103228 · MAX
Theken Spine, LLC
Orthopedic · 64d
Cleared Jan 05, 2011
SYNTHES 6.0 COCR AND CPT TI-3 RODS
K103287 · NKB
Synthes Spine
Orthopedic · 65d
Cleared Jan 04, 2011
CONGRUENT BONE PLATE SYSTEM
K102998 · HRS
Acumed, LLC
Orthopedic · 88d
Cleared Jan 03, 2011
F20
K103433 · NDN
Teknimed, S.A.
Orthopedic · 40d
Cleared Dec 29, 2010
ZENIUS SPINAL SYSTEM
K103272 · MNI
Medyssey Co, Ltd.
Orthopedic · 54d
Cleared Dec 28, 2010
ACL TIGHTROPE DOUBLE BUNDLE
K101837 · HTY
Arthrex, Inc.
Orthopedic · 180d