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
3745–3768 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 12, 2019
ISS-JAZZ Screw System and JAZZ CAP SP
K182771 · NKB
Implanet, S.A.
Orthopedic · 165d
Cleared Mar 12, 2019
ActivOrtho Nitinol Compression Screw System
K181610 · HWC
Activortho, Inc.
Orthopedic · 266d
Cleared Mar 11, 2019
EVOS Small Fragment Upper Extremity Plates Line Additions
K190253 · HRS
Smith & Nephew, Inc.
Orthopedic · 32d
Cleared Mar 11, 2019
Rotium Bioresorbable Wick
K183236 · MAI
Nanofiber Solutions, LLC
Orthopedic · 111d
Cleared Mar 08, 2019
Provident II Hip Stem
K190276 · LPH
Stelkast, Inc.
Orthopedic · 28d
Cleared Mar 08, 2019
Kuros TLIF Cage
K183092 · MAX
Kuros Biosciences B.V
Orthopedic · 121d
Cleared Mar 08, 2019
Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads
K182799 · KWS
Arthrex, Inc.
Orthopedic · 157d
Cleared Mar 07, 2019
Duo Lumbar Interbody Fusion Device
K190055 · MAX
Spineology, Inc.
Orthopedic · 55d
Cleared Mar 07, 2019
Spectrum Spine Expandable Cages (SSEC)
K173518 · MAX
Spectrum Spine, LLC
Orthopedic · 478d
Cleared Mar 06, 2019
ChoiceSpine Stealth Cervical Spacer System
K183397 · ODP
Choicespine, LP
Orthopedic · 89d
Cleared Mar 05, 2019
Stryker SternalPlate System
K183172 · HRS
Stryker
Orthopedic · 109d
Cleared Mar 04, 2019
SCARLET® AC-T Secured Anterior Cervical Cage
K190322 · ODP
Spineart
Orthopedic · 19d
Cleared Mar 04, 2019
SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices
K190193 · MAX
Spineex, Inc.
Orthopedic · 28d
Cleared Mar 04, 2019
MLP Special Locking Bone Plate System
K181843 · HRS
Maxxion Medical, LLC / Baumer SA
Orthopedic · 236d
Cleared Mar 01, 2019
IdentiTi Porous Ti Interbody System
K183705 · MAX
Alphatec Spine, Inc.
Orthopedic · 60d
Cleared Mar 01, 2019
Tenodesis Screw System
K183690 · MBI
Paragon 28, Inc.
Orthopedic · 60d
Cleared Mar 01, 2019
Idys™ TLIF TiVac
K183259 · MAX
Clariance, Sas
Orthopedic · 100d
Cleared Mar 01, 2019
CurvaFix Intramedullary Rodscrew System
K180050 · HWC
Curvafix, Inc.
Orthopedic · 417d
Cleared Feb 28, 2019
Austin Miller Large External Fixation System
K181528 · KTT
Austin Miller Trauma, LLC
Orthopedic · 262d
Cleared Feb 26, 2019
HEALIX ADVANCE SP PEEK Anchor
K182941 · MBI
Medos International SARL
Orthopedic · 126d
Cleared Feb 25, 2019
Perla® Posterior Cervico-Thoracic Fixation System
K190071 · NKG
Spineart
Orthopedic · 41d
Cleared Feb 22, 2019
Choice Spine Hawkeye Vertebral Body Replacement (VBR) System
K183588 · MQP
Choicespine
Orthopedic · 63d
Cleared Feb 22, 2019
Libertas Acetabular Hooded Liner
K183365 · LZO
Maxx Orthopedics, Inc.
Orthopedic · 80d
Cleared Feb 22, 2019
Altus Spine Interbody Fusion System
K182406 · MAX
Altus Partners, LLC
Orthopedic · 171d