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
3241–3264 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 31, 2020
TTC Phantom® Intramedullary Nail System
K192163 · HSB
Paragon 28, Inc.
Orthopedic · 175d
Cleared Jan 30, 2020
ATTUNE All-Polyethylene Tibia
K193057 · JWH
Depuy Ireland UC
Orthopedic · 90d
Cleared Jan 30, 2020
SCS 17-01
K190956 · MQV
Anika Therapeutics, Inc.
Orthopedic · 294d
Cleared Jan 29, 2020
Anatomical Shoulder System
K193099 · PHX
Zimmer GmbH
Orthopedic · 83d
Cleared Jan 29, 2020
MectaTap TI Suture Anchor
K191677 · MBI
Medacta International S.A.
Orthopedic · 219d
Cleared Jan 29, 2020
Quantum® Total Ankle Prosthesis
K191380 · HSN
In2bones Sas
Orthopedic · 251d
Cleared Jan 27, 2020
M.U.S.T. Pedicle Screw System
K193365 · NKB
Medacta International S.A.
Orthopedic · 54d
Cleared Jan 24, 2020
Persona Personalized Knee System
K193223 · JWH
Zimmer, Inc.
Orthopedic · 63d
Cleared Jan 24, 2020
APTUS Clavicle System
K192984 · HRS
Medartis AG
Orthopedic · 91d
Cleared Jan 24, 2020
SYPMHONY™ OCT System
K192014 · NKG
Medos International SARL
Orthopedic · 179d
Cleared Jan 24, 2020
Paratrooper Plantar Plate Repair System
K191227 · MBI
Paragon 28, Inc.
Orthopedic · 262d
Cleared Jan 23, 2020
Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor
K193295 · MBI
Parcus Medical, LLC
Orthopedic · 57d
Cleared Jan 22, 2020
Y-Knot OneStep Anchor
K193606 · MBI
Conmed Corporation
Orthopedic · 30d
Cleared Jan 22, 2020
SCARLET AL-T
K192993 · OVD
Spineart
Orthopedic · 89d
Cleared Jan 22, 2020
Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion...
K192502 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 132d
Cleared Jan 21, 2020
Nexxt Matrixx System
K193370 · MAX
Nexxt Spine, LLC
Orthopedic · 47d
Cleared Jan 20, 2020
Tyber Medical Anatomical Plating System
K193222 · HRS
Tyber Medical, LLC
Orthopedic · 59d
Cleared Jan 17, 2020
CoLink Plating System, Fracture and Correction System, CoLink Mini Plating...
K193543 · HRS
In2bones USA, LLC
Orthopedic · 28d
Cleared Jan 17, 2020
Black Diamond Navigation Instruments
K192495 · OLO
Osseus Fusion Systems
Orthopedic · 128d
Cleared Jan 16, 2020
ALLthread Titanium Suture Anchor
K192942 · MBI
Biomet, Inc.
Orthopedic · 90d
Cleared Jan 16, 2020
AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip
K192750 · MBI
Parcus Medical, LLC
Orthopedic · 108d
Cleared Jan 16, 2020
MobiliT Cup
K191831 · LZO
Corin U.S.A. Limited
Orthopedic · 191d
Cleared Jan 15, 2020
Arthrex SwiveLock Suture Anchor
K193503 · MAI
Arthrex, Inc.
Orthopedic · 28d
Cleared Jan 15, 2020
NEX-D2 Posterior Fixation System
K190981 · NKB
Next Orthosurgical
Orthopedic · 275d