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
145–168 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
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