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
2977–3000 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 22, 2020
True Tulip System, True M.I.S. System
K201780 · NKB
Innovative Surgical Designs, Inc.
Orthopedic · 22d
Cleared Jul 22, 2020
Pedicle Screw System
K201751 · NKB
Black Box Medical, LLC
Orthopedic · 26d
Cleared Jul 22, 2020
EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)
K201527 · HRS
Smith & Nephew, Inc.
Orthopedic · 44d
Cleared Jul 22, 2020
Gamma3 System
K200869 · HSB
Stryker Trauma GmbH
Orthopedic · 112d
Cleared Jul 22, 2020
DAC Dynamic Active Compression Plate
K200513 · HRS
Pioneer Surgical Technology, Inc.,...
Orthopedic · 142d
Cleared Jul 20, 2020
Smith+Nephew Arthroscopes
K201349 · HRX
Smith & Nephew
Orthopedic · 60d
Cleared Jul 17, 2020
LINK TrabecuLink Femoral Cones
K201364 · MBH
Waldemar Link GmbH & Co. KG
Orthopedic · 56d
Cleared Jul 17, 2020
Phantom® Hindfoot TTC/TC Nail System
K201227 · HSB
Paragon 28, Inc.
Orthopedic · 72d
Cleared Jul 16, 2020
Barricaid Instrument Tray
K201676 · QHG
Intrinsic Therapeutics, Inc.
Orthopedic · 27d
Cleared Jul 16, 2020
REDUCT® Headless Compression Screw System
K201662 · HWC
Skeletal Dynamics, Inc.
Orthopedic · 27d
Cleared Jul 16, 2020
KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular...
K201660 · OQG
Kyocera Medical Technologies, Inc.
Orthopedic · 28d
Cleared Jul 16, 2020
TiN Coated Humeral Head
K191698 · KWT
Fx Shoulder USA, Inc.
Orthopedic · 387d
Cleared Jul 16, 2020
ZCA All-Poly Acetabular Cups
K191449 · JDI
Zimmer, Inc.
Orthopedic · 412d
Cleared Jul 15, 2020
TxTiHA IBF System, AxTiHA Stand-Alone ALIF System
K201614 · MAX
Innovasis, Inc.
Orthopedic · 30d
Cleared Jul 15, 2020
EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT...
K201605 · MAX
Eit Emerging Implant Technologies GmbH
Orthopedic · 30d
Cleared Jul 15, 2020
CoLink Plating System
K201149 · HRS
In2bones USA, LLC
Orthopedic · 77d
Cleared Jul 15, 2020
Humelock TiN Coated Glenosphere
K191146 · PHX
Fx Shoulder USA, Inc.
Orthopedic · 442d
Cleared Jul 14, 2020
Mako Total Knee Application
K193515 · OLO
Mako Surgical Corp.
Orthopedic · 208d
Cleared Jul 10, 2020
Triathlon Total KneeSystem
K201343 · JWH
Howmedica Osteonics Corp., Dba...
Orthopedic · 51d
Cleared Jul 10, 2020
NextAR TKA Platform
K193559 · SBF
Medacta Inernational SA
Orthopedic · 200d
Cleared Jul 10, 2020
Paragon 28 APEX 3D Total Ankle Replacement System
K192994 · HSN
Paragon 28, Inc.
Orthopedic · 259d
Cleared Jul 09, 2020
Zimmer, Inc. Hip Joint Prostheses MR Labeling I
K200823 · JDI
Zimmer, Inc.
Orthopedic · 101d
Cleared Jul 08, 2020
Intraosseous Fixation System
K201556 · HWC
Extremity Medical, LLC
Orthopedic · 28d
Cleared Jul 08, 2020
Arthrex Eclipse Shoulder Prosthesis System
K201542 · PKC
Arthrex, Inc.
Orthopedic · 29d