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
1081–1104 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 06, 2024
Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)
K232996 · MAX
Shanghai Iatrical-Ti Technologies CO...
Orthopedic · 350d
Cleared Sep 05, 2024
Adaptix™ PEEK Interbody System with Nanotechnology
K241605 · MAX
Nanovis, LLC
Orthopedic · 93d
Cleared Sep 05, 2024
Fine Osteotomy™
K241356 · HRS
Bodycad Laboratories, Inc.
Orthopedic · 114d
Cleared Sep 03, 2024
Eminent Spine Scoliosis Deformity Pedicle Screw System
K242069 · NKB
Eminent Spine
Orthopedic · 50d
Cleared Sep 03, 2024
EVOS Patella Plates
K240487 · HRS
Smith & Nephew
Orthopedic · 196d
Cleared Aug 31, 2024
Arthrex VAL and VAL KreuLock™ Compression Screw System
K241592 · HWC
Arthrex, Inc.
Orthopedic · 89d
Cleared Aug 30, 2024
Conformity Stem Extension Line
K242249 · LZO
United Orthopedic Corporation
Orthopedic · 30d
Cleared Aug 30, 2024
Cadence Ankle PSI System
K241326 · OYK
3D Systems, Inc.
Orthopedic · 112d
Cleared Aug 30, 2024
Salto Talaris Ankle PSI System
K241148 · OYK
3D Systems, Inc.
Orthopedic · 127d
Cleared Aug 30, 2024
Orthopeasia Spinal Fixation System
K240180 · NKB
Orthopeasia Co., Ltd.
Orthopedic · 220d
Cleared Aug 29, 2024
VersaTap™ Suture Anchor (ADP050)
K242296 · MBI
Ortho-Design (Pty), Ltd.
Orthopedic · 27d
Cleared Aug 29, 2024
Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal...
K242280 · MQV
Stryker Spine
Orthopedic · 27d
Cleared Aug 28, 2024
OSSIOfiber® Compression Staple
K241932 · MNU
OSSIO , Ltd.
Orthopedic · 58d
Cleared Aug 28, 2024
REDEMPTION Charcot Plating System
K233816 · HRS
Vilex, LLC
Orthopedic · 272d
Cleared Aug 27, 2024
Q Guidance System
K241517 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 90d
Cleared Aug 27, 2024
Z1 Cemented Hip System
K241241 · LZO
Orchard Medical Development, LLC
Orthopedic · 116d
Cleared Aug 23, 2024
TMINI Miniature Robotic System
K242264 · OLO
THINK Surgical, Inc.
Orthopedic · 22d
Cleared Aug 23, 2024
SITTER 3.5mm Versatile System
K240318 · HRS
Bonebridge AG
Orthopedic · 203d
Cleared Aug 22, 2024
TRIGEN INTERTAN 10S Nail System
K241804 · JDS
Smith & Nephew, Inc.
Orthopedic · 62d
Cleared Aug 22, 2024
Phantom Fibula Nail System
K234128 · HSB
Paragon 28, Inc.
Orthopedic · 238d
Cleared Aug 22, 2024
Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking...
K230071 · HSB
Tdm Co., Ltd.
Orthopedic · 590d
Cleared Aug 21, 2024
TiLink-P SI Joint Fusion System
K242141 · OUR
SurGenTec, LLC
Orthopedic · 30d
Cleared Aug 21, 2024
Montage-XT Settable, Resorbable Bone Putty
K233566 · MQV
Orthocon, Inc.
Orthopedic · 289d
Cleared Aug 20, 2024
PYXIS 3D Titanium Cervical Cage system
K241738 · ODP
GS Medical Co., Ltd.
Orthopedic · 64d