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
7945–7968 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 08, 2011
PROW FUSION
K112359 · MAX
Nlt Spine, Ltd.
Orthopedic · 84d
Cleared Nov 07, 2011
SYNTHES ZERO-P VARIABLE ANGLE (VA)
K112068 · OVE
Synthes Spine Co.Lp
Orthopedic · 110d
Cleared Nov 04, 2011
ASCENSION NUGRIP CMC IMPLANT
K112278 · KYI
Ascension Orthopedic
Orthopedic · 87d
Cleared Nov 04, 2011
MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZED, UNOCATED /...
K112285 · JWH
Tgm Medical, Inc.
Orthopedic · 87d
Cleared Nov 04, 2011
TRIMED CLAVICLE FIXATION SYSTEM
K112509 · HRS
TriMed, Inc.
Orthopedic · 66d
Cleared Nov 03, 2011
AEQUALIS SHOULDER SYSTEM
K111902 · KWS
Tornier
Orthopedic · 121d
Cleared Nov 02, 2011
DYNA-EXTOR II
K110426 · KTT
Bk Meditech, Co., Ltd.
Orthopedic · 261d
Cleared Nov 02, 2011
LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM
K112931 · NKB
Phygen, LLC
Orthopedic · 30d
Cleared Nov 02, 2011
NANO SUTURE ANCHOR
K112965 · MBI
Linvatec Corporation D/B/A Conmed...
Orthopedic · 28d
Cleared Oct 31, 2011
DISTAL VOLAR RADIUS PLATING SYSTEMS
K112345 · LXT
Medos International SARL
Orthopedic · 77d
Cleared Oct 28, 2011
DUOCENTRIC REVERSED
K103251 · PHX
Aston Medical
Orthopedic · 359d
Cleared Oct 27, 2011
MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM
K110655 · NKB
Mahe Medical GmbH
Orthopedic · 234d
Cleared Oct 27, 2011
INVIZIA ANTERIOR CERVICAL PLATE SYSTEM
K111796 · KWQ
Zimmer Spine, Inc.
Orthopedic · 122d
Cleared Oct 26, 2011
EXPEDIUM SPINE SYSTEM
K110551 · NKB
Johnson & Johnson
Orthopedic · 240d
Cleared Oct 26, 2011
BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM
K111512 · MAX
Thompson Mis, Inc.
Orthopedic · 147d
Cleared Oct 26, 2011
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
K112174 · HRS
Zimmer, Inc.
Orthopedic · 90d
Cleared Oct 26, 2011
SYNTHES STERNAL FIXATION SYSTEM
K112689 · HRS
Synthes, Inc.
Orthopedic · 41d
Cleared Oct 25, 2011
AFFIRM (TM) VCF SYSTEM
K110998 · NDN
Algea Therapies
Orthopedic · 197d
Cleared Oct 25, 2011
VUSION(R) OS
K111965 · MAX
Ortho Development
Orthopedic · 106d
Cleared Oct 25, 2011
HEALIX KNOTLESS(TM) ANCHOR
K112249 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 81d
Cleared Oct 24, 2011
MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES
K102387 · JDR
Mediscope Manufacturing, Inc.
Orthopedic · 427d
Cleared Oct 24, 2011
LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT
K103513 · HRS
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 328d
Cleared Oct 24, 2011
VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE
K110783 · MAX
L & K Biomed Co., Ltd.
Orthopedic · 217d
Cleared Oct 24, 2011
FRAMEWALKER
K111993 · KTT
Quantum Medical Concepts, LLC
Orthopedic · 103d