FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
2185–2208 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 17, 2022
Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase...
K220452 · QHE
Materialise NV
Orthopedic · 181d
Cleared Aug 17, 2022
implaFit® hip stems
K210678 · LZO
Implantcast GmbH
Orthopedic · 530d
Cleared Aug 16, 2022
FairFix Adjustable Button System
K222169 · MBI
Medacta International S.A.
Orthopedic · 26d
Cleared Aug 12, 2022
aprevo® anterior and lateral lumbar interbody fusion devices, aprevo®...
K222082 · MAX
Carlsmed, Inc.
Orthopedic · 28d
Cleared Aug 12, 2022
Zavation VariSync Plate System and VariSync Spacer System
K221049 · OVE
Zavation Medical Products, LLC
Orthopedic · 123d
Cleared Aug 11, 2022
Arthrex Knotless FiberTak Biceps Suture Anchor
K222161 · MBI
Arthrex, Inc.
Orthopedic · 22d
Cleared Aug 11, 2022
Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem
K220731 · MEH
Stryker
Orthopedic · 150d
Cleared Aug 09, 2022
NextGen Pedicle Screw System
K221776 · NKB
Corelink, LLC
Orthopedic · 49d
Cleared Aug 09, 2022
“POINT” Kinguide Robotic-Assisted Surgical System
K220241 · OLO
Point Robotics MedTech, Inc.
Orthopedic · 193d
Cleared Aug 05, 2022
Spineology Navigation Instruments
K213876 · OLO
Spineology, Inc.
Orthopedic · 235d
Cleared Aug 05, 2022
Unispace SA Cervical Cage
K213791 · OVE
Edisoninno Co., Ltd.
Orthopedic · 242d
Cleared Aug 04, 2022
Actera™ hip system
K221104 · MEH
Conformis, Inc.
Orthopedic · 112d
Cleared Aug 04, 2022
CenterMed Patient Matched Assisted Surgical Planning (ASP) System
K211614 · PBF
Centermed, Inc.
Orthopedic · 435d
Cleared Aug 03, 2022
Cannulated Screws
K213614 · HWC
Maxxion Medical, LLC
Orthopedic · 261d
Cleared Jul 29, 2022
S-Core Implant System
K220901 · MBI
Subchondral Solutions, Inc.
Orthopedic · 123d
Cleared Jul 29, 2022
OptiVu ROSA MxR
K220733 · SBF
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 137d
Cleared Jul 29, 2022
Auxilock Titanium Screw-In Suture Anchor
K213104 · MBI
Auxein Medical Private Limited
Orthopedic · 308d
Cleared Jul 28, 2022
INERTIA CONNEXX Modular Pedicle Screw System
K221905 · NKB
Nexxt Spine, LLC
Orthopedic · 28d
Cleared Jul 28, 2022
OsteoCentric Spine MIS Pedicle Fastener System
K221332 · NKB
OsteoCentric Technologies
Orthopedic · 80d
Cleared Jul 27, 2022
Pegasus-X Expandable PLIF System
K221687 · MAX
GS Medical Co., Ltd.
Orthopedic · 47d
Cleared Jul 27, 2022
Real Intelligence Cori
K220958 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 117d
Cleared Jul 27, 2022
TransLoc 3D
K211496 · OUR
Foundation Fusion Solutions, LLC (Dba...
Orthopedic · 440d
Cleared Jul 27, 2022
KeriFlex® MCP and PIP Finger Joint Prostheses
K211385 · KYJ
Keri Medical SA
Orthopedic · 449d
Cleared Jul 26, 2022
Cemented Round Patella with JRNY Pegs
K221939 · JWH
Smith & Nephew, Inc.
Orthopedic · 25d