FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,899 results
193–216 of 17,899
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 25, 2026
Airlock® Ankle Plating System
K260274 · HRS
Novastep SAS
Orthopedic · 55d
Cleared Mar 25, 2026
Invictus Bands System
K253615 · OWI
Alphatec Spine, Inc.
Orthopedic · 127d
Cleared Mar 25, 2026
Flex-Z™ Cervical Cage
K252432 · ODP
Spinepoint, LLC
Orthopedic · 236d
Cleared Mar 25, 2026
CUVIS-joint (CJ150)
K252037 · OLO
Curexo, Inc.
Orthopedic · 268d
Cleared Mar 24, 2026
LOQTEQ® VA Proximal Humerus Plate 3.5
K254253 · HRS
Aap Implantate AG
Orthopedic · 85d
Cleared Mar 23, 2026
QuikFix External Fixator: Knee-Spanning Pack
K260112 · KTT
Stabiliz Orthopaedics, Inc.
Orthopedic · 68d
Cleared Mar 23, 2026
Clavicle Fixation System
K254288 · HRS
Skeletal Dynamics, Inc.
Orthopedic · 82d
Cleared Mar 20, 2026
Arthrex FiberTak Suture Anchor
K260561 · MBI
Arthrex, Inc.
Orthopedic · 29d
Cleared Mar 20, 2026
TiLink-L Navigation Instruments
K253604 · OLO
SurGenTec, LLC
Orthopedic · 122d
Cleared Mar 20, 2026
Arthrex Humeral Nails
K252016 · HSB
Arthrex, Inc.
Orthopedic · 266d
Cleared Mar 19, 2026
CastleLoc Pectus Bar System
K260448 · HRS
L & K Biomed Co., Ltd.
Orthopedic · 36d
Cleared Mar 19, 2026
DiversiVy™ Facet Screw System
K253432 · MRW
Vy Spine, LLC
Orthopedic · 169d
Cleared Mar 18, 2026
DynaNail Mini
K254110 · HWC
MedShape, Inc.
Orthopedic · 89d
Cleared Mar 18, 2026
EUROPA™ Posterior Cervical Fusion Navigated Instruments
K253444 · OLO
MiRus, LLC
Orthopedic · 167d
Cleared Mar 18, 2026
Fusion FibFix Nail
K252961 · HSB
Fusion Orthopedics USA, LLC
Orthopedic · 183d
Cleared Mar 17, 2026
Q Pedicle Instruments
K260546 · OLO
K2m, Inc.
Orthopedic · 27d
Cleared Mar 17, 2026
Super Upper Limbs Versalock Plating System
K260390 · HRS
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 39d
Cleared Mar 17, 2026
APS Spear Locking Plate
K254053 · HRS
A Plus Biotechnology Co., Ltd.
Orthopedic · 90d
Cleared Mar 17, 2026
Grappler Suture Anchor PCFD Tether System
K253886 · MBI
Paragon 28, Inc.
Orthopedic · 103d
Cleared Mar 16, 2026
SINEFIX
K254176 · MBI
BAAT Medical Products B.V.
Orthopedic · 83d
Cleared Mar 16, 2026
CarboClear® Posterior Cervical Screw System
K254045 · NKG
CarboFix Orthopedics , Ltd.
Orthopedic · 89d
Cleared Mar 16, 2026
APTUS Shoulder Proximal Humerus System, PentaLock 3.5
K253916 · HRS
Medartis AG
Orthopedic · 98d
Cleared Mar 12, 2026
Affixus Retrograde Femoral Nailing System
K253566 · HSB
Zimmer, Inc.
Orthopedic · 115d
Cleared Mar 12, 2026
Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head
K252824
Signature Orthopaedics Pty, Ltd.
Orthopedic · 188d