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
2737–2760 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 06, 2021
DRPx Locking Distal Radius Plate System
K202971 · HRS
Orthopaedic Implant Company
Orthopedic · 218d
Cleared May 05, 2021
OIC External Fixation System
K211112 · KTT
Orthopaedic Implant Company
Orthopedic · 21d
Cleared May 05, 2021
Genius / Genuin Total Knee System
K200765 · JWH
Biorad Medisys Pvt, Ltd.
Orthopedic · 407d
Cleared May 04, 2021
CoLink Sfx Implant System
K203698 · HTY
In2bones USA, LLC
Orthopedic · 137d
Cleared May 04, 2021
CaP Spheres Pellet Pack
K203218 · MQV
Zimmer Biomet Spine, Inc.
Orthopedic · 183d
Cleared May 04, 2021
A-Link Z
K201671 · OVD
Acuity Surgical Devices, LLC
Orthopedic · 319d
Cleared Apr 30, 2021
CD Horizon™ Spinal System
K210637 · NKB
Medtronic
Orthopedic · 58d
Cleared Apr 30, 2021
JACE Medical Thoracic Plating System
K210290 · HRS
Jace Medical, LLC
Orthopedic · 87d
Cleared Apr 30, 2021
OsteoCentric Integrated Hip Fastener System
K210247 · JDO
Osteocentric Technologies D.B.A....
Orthopedic · 91d
Cleared Apr 30, 2021
ProLift Lateral HELO Fixated
K210061 · MAX
Life Spine, Inc.
Orthopedic · 109d
Cleared Apr 29, 2021
Expandable Titanium PLIF/TLIF System
K201024 · MAX
Spectrum Spine, LLC
Orthopedic · 374d
Cleared Apr 28, 2021
BI-MENTUM™ ALTRX® Dual Mobility Liner
K203532 · LZO
Depuy Ireland UC
Orthopedic · 147d
Cleared Apr 28, 2021
MPACT Extension
K200391 · LPH
Medacta International S.A.
Orthopedic · 435d
Cleared Apr 27, 2021
Responsive Arthroscopy Thunderbolt System
K203121 · MBI
Responsive Arthroscopy, LLC
Orthopedic · 193d
Cleared Apr 23, 2021
GPS Cervical Spacers
K210890 · ODP
G Surgical, LLC
Orthopedic · 29d
Cleared Apr 23, 2021
SteriTrak
K203605 · JEC
Arbutus Medical, Inc.
Orthopedic · 134d
Cleared Apr 22, 2021
Restoration Anatomic Shell
K210893 · LPH
Howmedica Osteonics Corp. A.K.A....
Orthopedic · 28d
Cleared Apr 22, 2021
ARx Spinal System
K210549 · NKB
Life Spine, Inc.
Orthopedic · 56d
Cleared Apr 22, 2021
MY01 Continuous Compartmental Pressure Monitor
K210525 · LXC
MY01, Inc.
Orthopedic · 58d
Cleared Apr 22, 2021
Medline UNITE REFLEX Nitinol Staple System
K210482 · JDR
Medline Industries, Inc.
Orthopedic · 62d
Cleared Apr 21, 2021
U2 Total Knee System, XPE Tibial Insert, PS PLUS
K210961 · JWH
United Orthopedic Corporation
Orthopedic · 21d
Cleared Apr 21, 2021
MOBIO Total Knee System
K210483 · JWH
B-One Ortho, Corp.
Orthopedic · 61d
Cleared Apr 21, 2021
Knee+
K202750 · SBF
Pixee Medical
Orthopedic · 212d
Cleared Apr 21, 2021
si-Mochi
K202639 · MQV
Biostone, Ltd.
Orthopedic · 222d