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
529–552 of 17,899
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 18, 2025
Arthrex FiberTak Suture Anchor
K251809 · MBI
Arthrex, Inc.
Orthopedic · 36d
Cleared Jul 18, 2025
VersaCoat Tendon Protector (VTP-44G2)
K251655 · OWW
Alafair Biosciences
Orthopedic · 49d
Cleared Jul 18, 2025
Baby Gorilla®/Gorilla® Plating System
K250952 · HRS
Paragon 28, Inc.
Orthopedic · 112d
Cleared Jul 17, 2025
Device 300423 Granules
K251556 · MQV
Geistlich Pharma AG
Orthopedic · 57d
Cleared Jul 17, 2025
MectaLIF 3D Metal
K251016 · MAX
Medacta International S.A.
Orthopedic · 106d
Cleared Jul 15, 2025
Jewel Soft Tissue Reinforcement Device (102-6005)
K242237 · QUW
Xiros Limited
Orthopedic · 350d
Cleared Jul 14, 2025
Phantom® Hindfoot TTC/TC Nail System
K251850 · HSB
Paragon 28, Inc.
Orthopedic · 28d
Cleared Jul 14, 2025
Materialise TKA Guide System
K251554 · JWH
Materialise NV
Orthopedic · 54d
Cleared Jul 14, 2025
The Acumed Wrist Fixation System - Plates
K251132 · HRS
Acumed, LLC
Orthopedic · 94d
Cleared Jul 11, 2025
Resolve Anterior Cervical Plate System
K251436 · KWQ
Pioneer Surgical Technology, Inc.
Orthopedic · 64d
Cleared Jul 11, 2025
RipCord
K251134 · HTN
TriMed, Inc.
Orthopedic · 91d
Cleared Jul 10, 2025
TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)
K251945 · HRS
TriMed, Inc.
Orthopedic · 15d
Cleared Jul 10, 2025
CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant
K251885 · MRW
Providence Medical Technology, Inc.
Orthopedic · 20d
Cleared Jul 10, 2025
Arthrex PushLock Suture Anchors
K251145 · MBI
Arthrex, Inc.
Orthopedic · 87d
Cleared Jul 10, 2025
CONDUIT™ SYNFIX™ Evolution Secured Spacer System
K250072 · OVD
Avalign Technologies, Inc.
Orthopedic · 181d
Cleared Jul 09, 2025
panaSIa SI Fusion System
K250247 · OUR
Wenzel Spine, Inc.
Orthopedic · 163d
Cleared Jul 09, 2025
OptiVu™ Shoulder
K250108 · SBF
Mr Surgical Solutions, LLC
Orthopedic · 174d
Cleared Jul 08, 2025
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K251804 · NKB
S.M.A.I.O
Orthopedic · 26d
Cleared Jul 08, 2025
EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)
K251776 · JWH
Encore Medical, L.P.
Orthopedic · 28d
Cleared Jul 08, 2025
PathLoc Lumbar Interbody Fusion Cage System
K251741 · MAX
L & K Biomed Co., Ltd.
Orthopedic · 32d
Cleared Jul 08, 2025
ExcelsiusXR™
K241525 · SBF
Globus Medical, Inc.
Orthopedic · 404d
Cleared Jul 07, 2025
TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System
K251502 · MAX
Life Spine, Inc.
Orthopedic · 53d
Cleared Jul 07, 2025
aprevo® anterior lumbar interbody fusion device
K250827 · MAX
Carlsmed, Inc.
Orthopedic · 111d
Cleared Jul 03, 2025
IdentiTi II Cervical Interbody System
K251080 · ODP
Alphatec Spine, Inc.
Orthopedic · 86d