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
6793–6816 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 09, 2013
HUMELOCK II CEMENTLESS SHOULDER SYSTEM
K130759 · HSD
Fx Solutions
Orthopedic · 234d
Cleared Nov 09, 2013
CAYMAN MI PLATE SYSTEM
K131533 · KWQ
K2m, Inc.
Orthopedic · 168d
Cleared Nov 08, 2013
ORTHOALIGN PLUS SYSTEM
K130387 · OLO
Orthalign, Inc.
Orthopedic · 266d
Cleared Nov 08, 2013
ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM
K131767 · ONN
Orthosensor, Inc.
Orthopedic · 144d
Cleared Nov 08, 2013
PASS LP SPINAL SYSTEM
K132574 · OSH
Medicrea International
Orthopedic · 84d
Cleared Nov 05, 2013
GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT...
K132241 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 110d
Cleared Nov 04, 2013
MECTACER BIOLOX OPTION HEADS
K131518 · LZO
Medacta International
Orthopedic · 160d
Cleared Nov 04, 2013
ARIX HAND SYSTEM
K131566 · HRS
Jeil Medical Corporation
Orthopedic · 158d
Cleared Nov 04, 2013
WOLF LONG BONE PLATE SYSTEM
K131834 · HRS
Toby Orthopaedics
Orthopedic · 137d
Cleared Nov 01, 2013
PERIMETER INTERBODY FUSION DEVICE
K131669 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 147d
Cleared Nov 01, 2013
HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS)
K132883 · HRX
Hemodia Sas
Orthopedic · 49d
Cleared Oct 31, 2013
GSB GLOBAL SPINAL BALANCE SYSTEM
K132014 · NKB
Nuvasive, Inc.
Orthopedic · 122d
Cleared Oct 31, 2013
ALTUS SPINE PEDICLE SCREW SYSTEM
K132280 · MNI
Altus Partners
Orthopedic · 100d
Cleared Oct 30, 2013
PLASMAFIT ACETABULAR CUP AND VITELENE INSERT
K122783 · OQG
Aesculap Implant System, Inc.
Orthopedic · 414d
Cleared Oct 30, 2013
ARTHREX UNIVERS II CA HEADS
K130675 · HSD
Arthrex, Inc.
Orthopedic · 231d
Cleared Oct 30, 2013
U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTER
K131116 · JWH
United Orthopedic Corporation
Orthopedic · 191d
Cleared Oct 30, 2013
FLOWER BONE SCREW SET
K132248 · HWC
Flower Orthopedics Corporation
Orthopedic · 103d
Cleared Oct 29, 2013
REVERSE SHOULDER PROSTHESIS MONOBLOCK
K130048 · KWS
Encore Medical, L.P.
Orthopedic · 294d
Cleared Oct 29, 2013
BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM
K130274 · MAX
Elite Surgical Supplies (Pty), Ltd.
Orthopedic · 267d
Cleared Oct 29, 2013
2.5MM INLINE FUSION PLATE
K131867 · HRS
Biomet, Inc.
Orthopedic · 127d
Cleared Oct 28, 2013
SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM
K132126 · MRW
Spectrum Spine, LLC
Orthopedic · 110d
Cleared Oct 28, 2013
NAUTILUS SPINAL SYSTEM
K132866 · NKB
Life Spine, Inc.
Orthopedic · 45d
Cleared Oct 25, 2013
MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM
K132900 · KWP
Intelligent Implant Systems, LLC
Orthopedic · 39d
Cleared Oct 24, 2013
MAK OSS FEMORAL KNEE COMPONENTS
K131393 · KRO
Biomet Orthopedics Corp.
Orthopedic · 162d