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
73–96 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 18, 2026
BluEX Cervical Expandable Cage System
K262489 · ODP
L & K Biomed Co., Ltd.
Orthopedic · 29d
Cleared Aug 14, 2026
BAGUERA® C Cervical Disc Surgical Instruments
K262639 · QLQ
Spineart SA
Orthopedic · 16d
Cleared Aug 13, 2026
MIKRON TRAUMA BONE PLATE& SCREW SYSTEM
K260277 · HRS
Mikron Makina San. ve Tic. Ltd. Sti.
Orthopedic · 196d
Cleared Aug 12, 2026
Large Compression Screws
K262344 · HWC
TriMed, Inc.
Orthopedic · 33d
Cleared Aug 10, 2026
Icona Hip Stem
K261576 · MEH
Corin, Ltd.
Orthopedic · 90d
Cleared Aug 07, 2026
Arthrex Bioabsorbable PushLock Suture Anchors
K262357 · MAI
Arthrex, Inc.
Orthopedic · 28d
Cleared Aug 07, 2026
Freedom Total Knee System (E-Poly Tibial Liners)
K261563 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 88d
Cleared Aug 06, 2026
Triathlon® Knee System
K261898 · KRO
Howmedica Osteonics Corp., Dba...
Orthopedic · 62d
Cleared Aug 06, 2026
Megalodon Dynamic Compression System
K261121 · JDR
Paragon 28, Inc.
Orthopedic · 125d
Cleared Aug 05, 2026
GFS - Sterile Screws and Top Hat
K253858 · HWC
T.A.G. Medical Products Corporation,...
Orthopedic · 245d
Cleared Aug 04, 2026
Freedom Partial Knee System
K261609 · HSX
Maxx Orthopedics, Inc.
Orthopedic · 82d
Cleared Aug 04, 2026
TRIVANCE™ Hip Stem
K254043 · LPH
Globus Medical, Inc.
Orthopedic · 230d
Cleared Aug 03, 2026
Grappler Suture Anchor System
K262047 · MBI
Paragon 28, Inc.
Orthopedic · 46d
Cleared Aug 03, 2026
SABER-XA System
K261408 · OVD
Elevation Spine
Orthopedic · 95d
Cleared Jul 31, 2026
Lantern Knee Navigation Unit (406000-03)
K262253 · ONN
Orthalign, Inc.
Orthopedic · 29d
Cleared Jul 31, 2026
ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial...
K262251 · JWH
Globus Medical, Inc.
Orthopedic · 30d
Cleared Jul 31, 2026
xvision Spine system
K261854 · SBF
Augmedics, Ltd.
Orthopedic · 58d
Cleared Jul 31, 2026
Vertiwedge® Intraosseous System
K261810 · MQP
Foundation Surgical Group
Orthopedic · 60d
Cleared Jul 31, 2026
Interwedge® Standalone Lateral
K261809 · OVD
Foundation Surgical Group
Orthopedic · 60d
Cleared Jul 31, 2026
ZSAlign Cervical Interbody System
K261451 · OVE
Zsfab, Inc.
Orthopedic · 91d
Cleared Jul 30, 2026
AIR+ All-Inside Meniscal Repair Device, Curved Up
K262369 · MBI
Stryker Endoscopy
Orthopedic · 20d
Cleared Jul 30, 2026
Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral...
K261410 · OLO
Suite 201, National Innovation Centre
Orthopedic · 91d
Cleared Jul 30, 2026
Arthrex Radial Head Replacement System
K260624 · KWI
Arthrex, Inc.
Orthopedic · 154d
Cleared Jul 29, 2026
Suture Button Repair System
K261770 · MBI
Skeletal Dynamics, Inc.
Orthopedic · 61d