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
49–72 of 17,899
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 01, 2026
Admiral ACP System
K253420 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 273d
Cleared Jun 26, 2026
SALGINA 2.5mm Distal Radius System
K261351 · HRS
Bonebridge AG
Orthopedic · 63d
Cleared Jun 26, 2026
Arthrex FiberButton
K260018 · MBI
Arthrex, Inc.
Orthopedic · 172d
Cleared Jun 26, 2026
VERTICALE® Navigation Instruments
K253921 · OLO
Silony Medical GmbH
Orthopedic · 200d
Cleared Jun 25, 2026
ATTUNE Total Knee System
K261458 · JWH
Depuy Ireland UC
Orthopedic · 55d
Cleared Jun 25, 2026
Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System
K260809 · HWC
Arthrex, Inc.
Orthopedic · 105d
Cleared Jun 25, 2026
VELYS™ Robotic-Assisted Solution
K260480 · OLO
Depuy Ireland UC
Orthopedic · 132d
Cleared Jun 22, 2026
DeltaNEC Interbody System
K261279 · OVE
Nexus Spine
Orthopedic · 66d
Cleared Jun 20, 2026
Dynamis Robotic Surgical System
K260369 · OLO
LEM Surgical AG
Orthopedic · 135d
Cleared Jun 18, 2026
CORUS™ Navigation System-GN
K261665 · OLO
Providence Medical Technology, Inc.
Orthopedic · 29d
Cleared Jun 18, 2026
Precice™ Max System and Precice™ Ankle Salvage System
K261651 · HSB
NuVasive Specialized Orthopedics
Orthopedic · 30d
Cleared Jun 18, 2026
AND Medical Femoral Nail System (PFNA01)
K253080 · HSB
Suzhou and Science & Technology...
Orthopedic · 268d
Cleared Jun 18, 2026
CONDUIT™ ZERO-P™ VA Secured Spacer System
K252982 · OVE
Avalign Technologies, Inc.
Orthopedic · 274d
Cleared Jun 17, 2026
Fule Metallic Lockable Intramedullary Nail Systems
K253155 · HSB
Beijing Fule Science & Technology...
Orthopedic · 264d
Cleared Jun 17, 2026
“Socko” Vimax Spinal Fixation System
K253045 · NKB
Socko Medical Co., Ltd.
Orthopedic · 268d
Cleared Jun 16, 2026
Augment Off-Axis Instrument System
K261683 · PHX
Zimmer, Inc.
Orthopedic · 26d
Cleared Jun 16, 2026
I.T.S. Clavicle Plates with Angular Stability
K260958 · HRS
I.T.S. GmbH
Orthopedic · 85d
Cleared Jun 16, 2026
Z1 Hip System
K260831 · LZO
Zimmer, Inc.
Orthopedic · 95d
Cleared Jun 16, 2026
LimiFlex® Dynamic Sagittal Tether Instrument Set
K253374 · SGL
Empirical Spine
Orthopedic · 259d
Cleared Jun 16, 2026
Prophecy Incompass Surgical Planning System
K253159 · HSN
Wright Medical Technology, Inc....
Orthopedic · 263d
Cleared Jun 16, 2026
HERA Interlocking Intramedullary Nailing System
K253046 · HSB
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 267d
Cleared Jun 15, 2026
Dynamo™ Spinal Cement
K260286 · PML
Spine Wave, Inc.
Orthopedic · 137d
Cleared Jun 15, 2026
NeckTune™ 3D SA Cervical Cage
K260036 · OVE
Medyssey Co, Ltd.
Orthopedic · 160d
Cleared Jun 15, 2026
Fule Interbody Fusion Cage System
K253151 · MAX
Beijing Fule Science & Technology...
Orthopedic · 262d