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
9145–9168 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 24, 2009
BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS
K090299 · LZO
Aesculap Implant Systems
Orthopedic · 77d
Cleared Apr 24, 2009
PEDIPLATES
K090666 · HRS
OrthoPediatrics Corp.
Orthopedic · 42d
Cleared Apr 24, 2009
STRYKER SPINE AVS PL PEEK SPACERS
K090816 · MAX
Stryker Corp.
Orthopedic · 30d
Cleared Apr 24, 2009
MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS
K090839 · HRS
Syntec Scientific Corp.
Orthopedic · 28d
Cleared Apr 23, 2009
EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM
K082934 · HWC
Extremity Medical, LLC
Orthopedic · 204d
Cleared Apr 23, 2009
APTUS 2.0 RADIAL HEAD SYSTEM
K090053 · HRS
Medartis AG
Orthopedic · 105d
Cleared Apr 22, 2009
MERETE LOCKING BONE PLATE SYSTEM
K090063 · KTT
Merete Medical, Inc.
Orthopedic · 103d
Cleared Apr 22, 2009
AVS ANTERIOR LARGE PEEK SPACERS
K090166 · MAX
Stryker Corp.
Orthopedic · 90d
Cleared Apr 22, 2009
NOVEL ALIF SPINAL SPACER SYSTEM
K090782 · MAX
Alphatec Spine, Inc.
Orthopedic · 30d
Cleared Apr 22, 2009
MODIFICATION TO EXPEDIUM SPINE SYSTEM
K090799 · NKB
Depuy Spine, Inc.
Orthopedic · 29d
Cleared Apr 21, 2009
ALEUTIAN IBF SYSTEM
K082698 · MAX
K2m, Inc.
Orthopedic · 218d
Cleared Apr 21, 2009
NOVATION CFS PRESS-FIT AND CEMENTED STEMS
K090764 · LWJ
Exactech, Inc.
Orthopedic · 29d
Cleared Apr 20, 2009
CALIX SPINAL IMPLANT SYSTEM
K083637 · ODP
X-Spine Systems, Inc.
Orthopedic · 132d
Cleared Apr 20, 2009
LANX FUSION SYSTEM
K083815 · MAX
Lanx, Inc.
Orthopedic · 119d
Cleared Apr 20, 2009
MODIFICATION TO: S4 SPINAL SYSTEM
K090657 · NKB
Aesculap Implant Systems
Orthopedic · 39d
Cleared Apr 17, 2009
LATARJET CORTICAL SCREW SET
K083096 · HWC
Tag Medical Products
Orthopedic · 182d
Cleared Apr 17, 2009
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K090714 · KWP
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Apr 15, 2009
ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD)
K083714 · MAX
Titan Spine, LLC
Orthopedic · 121d
Cleared Apr 15, 2009
ENSPIRE DEBRIDER SYSTEM
K090278 · HRX
Spine View, Inc.
Orthopedic · 70d
Cleared Apr 15, 2009
NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD
K090731 · MQV
Novabone Products, LLC
Orthopedic · 27d
Cleared Apr 14, 2009
BONOS INJECT
K090460 · NDN
Aap Biomaterials GmbH
Orthopedic · 50d
Cleared Apr 10, 2009
CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES
K090186 · MAI
Linvatec Corp.
Orthopedic · 74d
Cleared Apr 09, 2009
CAMBRIA
K082309 · ODP
Seaspine, Inc.
Orthopedic · 239d
Cleared Apr 09, 2009
EMINENT SPINE INTERBODY FUSION SYSTEM
K090064 · MAX
Eminent Spine
Orthopedic · 90d