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
2881–2904 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 29, 2021
XYPAN Expandable Lumbar Cage System
K203531 · MAX
Aegis Spine, Inc.
Orthopedic · 58d
Cleared Jan 29, 2021
Prase-AP Anterior Cervical Plate System
K202878 · KWQ
Gbs Commonwealth Co., Ltd.
Orthopedic · 123d
Cleared Jan 29, 2021
Ti3Z Cervical Interbody System
K202398 · ODP
Zavation Medical Products, LLC
Orthopedic · 161d
Cleared Jan 29, 2021
PediFlex Flexible Nail System
K201838 · HTY
OrthoPediatrics Corp.
Orthopedic · 211d
Cleared Jan 29, 2021
BEE Cages
K200429 · ODP
NGMedical GmbH
Orthopedic · 343d
Cleared Jan 28, 2021
Vitality® Spinal Fixation System
K203507 · NKB
Zimmer Biomet Spine, Inc.
Orthopedic · 59d
Cleared Jan 28, 2021
Biomet Microfixation RibFix Advantage System
K203474 · HRS
Biomet Micofixation
Orthopedic · 64d
Cleared Jan 28, 2021
HipXpert 3D Display and Anchoring Application
K200384 · OSF
Surgical Planning Associates, Inc.
Orthopedic · 345d
Cleared Jan 27, 2021
EVOS Large Fragment Plating System
K203405 · HRS
Smith & Nephew, Inc.
Orthopedic · 69d
Cleared Jan 26, 2021
M.U.S.T. Pedicle Screw Extension and Long Tab Implants
K203482 · NKB
Medacta International S.A.
Orthopedic · 60d
Cleared Jan 26, 2021
Altus Spine HA Pedicle Screw System
K200922 · NKB
Altus Partners, LLC
Orthopedic · 295d
Cleared Jan 25, 2021
VERTACONNECT TLIF Cage
K203327 · MAX
Signus Medizintechnik
Orthopedic · 74d
Cleared Jan 22, 2021
Advanced Research Medical Trident SI Screw System
K203373 · OUR
Advanced Research Medical, LLC
Orthopedic · 67d
Cleared Jan 22, 2021
Flex-ThreadTM Distal Fibula Intramedullary Nail System
K202858 · HSB
Conventus Orthopaedics, LLC
Orthopedic · 116d
Cleared Jan 19, 2021
SnugFit All-Suture Anchor
K203485 · MBI
Medacta International S.A.
Orthopedic · 53d
Cleared Jan 19, 2021
CREO Stabilization System, Navigation Instruments, ExcelsiusGPS
K203153 · NKB
Globus Medical, Inc.
Orthopedic · 89d
Cleared Jan 19, 2021
Sequel External Fixation Device
K202833 · KTT
Sequel Medical, Inc.
Orthopedic · 116d
Cleared Jan 19, 2021
Biocore9 Femoral Head Resurfacing Component
K201219 · KXA
Biocore9, LLC
Orthopedic · 258d
Cleared Jan 15, 2021
CarboClear Lumbar Cage System
K203683 · MAX
Carbofix Orthpedics , Ltd.
Orthopedic · 29d
Cleared Jan 15, 2021
CD HORIZON™ Spinal System
K203678 · NQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Jan 15, 2021
PERLA® TL posterior osteosynthesis system
K203506 · NKB
Spineart
Orthopedic · 46d
Cleared Jan 15, 2021
Dynanail Mini Hybrid
K203381 · HWC
MedShape, Inc.
Orthopedic · 59d
Cleared Jan 15, 2021
Ali Interbody Fusion System
K203308 · MAX
Raed M. Ali, M.D., Inc.
Orthopedic · 66d
Cleared Jan 15, 2021
EBERLE Shaver System C3 and Accessories
K193608 · HRX
Eberle GmbH & Co. KG
Orthopedic · 386d