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
73–96 of 17,899
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 12, 2026
Exalta Proximal Tibia Plating System
K261207 · HRS
Tyber Medical, LLC
Orthopedic · 60d
Cleared Jun 12, 2026
Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented...
K260102 · PHX
Stryker Corporation (Tornier, Inc.)
Orthopedic · 150d
Cleared Jun 11, 2026
Ion-L
K261209 · MRW
SurGenTec, LLC
Orthopedic · 59d
Cleared Jun 11, 2026
MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System
K254087 · KTT
Synthes USA Products, LLC
Orthopedic · 175d
Cleared Jun 10, 2026
MSS - Humeral reverse liners extension
K261016 · PHX
Medacta International, SA
Orthopedic · 75d
Cleared Jun 10, 2026
Anteralign LS coverplate
K260810 · OVD
Tyber Medical, LLC
Orthopedic · 90d
Cleared Jun 10, 2026
LARS ACJ
K253115 · HTN
Movmedix S.A.S.
Orthopedic · 259d
Cleared Jun 09, 2026
TekBrace Solo Soft Tissue Reinforcement Device
K261621 · QUW
Theramicro
Orthopedic · 25d
Cleared Jun 09, 2026
Materialise Shoulder System™, Materialise Shoulder Guide and Models,...
K260802 · QHE
Materialise NV
Orthopedic · 90d
Cleared Jun 09, 2026
ChanPin Pedicle Screw Spinal System
K251251 · NKB
Chanpin Medtak Co., Ltd.
Orthopedic · 412d
Cleared Jun 08, 2026
ELEOS™ with NanoCept® Technology Limb Salvage System
K253066 · QZZ
Onkos Surgical, Inc.
Orthopedic · 259d
Cleared Jun 05, 2026
APTUS Clavicle System 2.8
K260761 · HRS
Medartis AG
Orthopedic · 88d
Cleared Jun 05, 2026
OsteoCool™ RF Ablation System
K253656 · GEI
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 197d
Cleared Jun 05, 2026
VEOFIX Snap Off Screw
K253108 · HWC
Steps Ortho
Orthopedic · 254d
Cleared Jun 05, 2026
iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma...
K243192 · LPH
Nextstep Arthopedix, LLC
Orthopedic · 613d
Cleared Jun 04, 2026
Signature™ ONE System
K261510 · QHE
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 28d
Cleared Jun 03, 2026
Permatage Flowable, Settable Hemostatic Bone Paste
K261439 · MTJ
Orthocon, Inc.
Orthopedic · 34d
Cleared Jun 02, 2026
Pectus Blu System
K261002 · HRS
Biomet Microfixation
Orthopedic · 68d
Cleared Jun 02, 2026
SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
K260571 · OLO
Life Spine, Inc.
Orthopedic · 103d
Cleared Jun 02, 2026
Device 300419 Strip
K260364 · MQV
Geistlich Pharma AG
Orthopedic · 118d
Cleared Jun 02, 2026
Packaged Assembly, Reusable Navigation Unit
K253507 · ONN
Orthalign, Inc.
Orthopedic · 211d
Cleared Jun 02, 2026
TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems
K253195 · NKG
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 249d
Cleared May 30, 2026
CoLink® & CoLag® Non-Sterile Screws
K261154 · HWC
In2bones USA, LLC
Orthopedic · 52d
Cleared May 29, 2026
Exceed® Biplanar Expandable Interbody System
K261159 · MAX
Spine Wave, Inc.
Orthopedic · 51d