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
1–24 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 02, 2026
OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts
K263116 · HWC
OsteoCentric Technologies
Orthopedic · 28d
Cleared Oct 02, 2026
ZSAlign Cervical Interbody System
K263113 · OVE
Zsfab, Inc.
Orthopedic · 28d
Cleared Oct 02, 2026
AltiVate Reverse® Glenosphere with RAVN™ Technology
K263086 · PHX
Encore Medical, L.P.
Orthopedic · 30d
Cleared Oct 02, 2026
Response Ortho Smart Fixator - Hexapod System
K263083 · KTT
Response Ortho Solutions, LLC
Orthopedic · 30d
Cleared Oct 02, 2026
TDM Large Bone Plate and Screw System
K261611 · HRS
Tdm Co., Ltd.
Orthopedic · 140d
Cleared Oct 02, 2026
Minuteman G6 MIS Fusion Plate
K261607 · PEK
Spinal Simplicity, LLC
Orthopedic · 141d
Cleared Oct 02, 2026
AnyPlus II Spinal Fixation System
K261217 · NKB
GS Medical Co., Ltd.
Orthopedic · 171d
Cleared Oct 01, 2026
NOVIX Pedicle Screw System
K263062 · NKB
Tdm Co., Ltd.
Orthopedic · 30d
Cleared Oct 01, 2026
NEXUS® Hip Stem
K262473 · LZO
Microport Orthopedics, Inc.
Orthopedic · 76d
Cleared Sep 30, 2026
SAS MIS Pelvic Incidence Rods
K263172 · NKB
Spinal Alignment Solutions, Inc.
Orthopedic · 20d
Cleared Sep 30, 2026
Duet™ Spinal Fixation System
K262712 · NKB
Duet Spine Holdings, LLC
Orthopedic · 61d
Cleared Sep 30, 2026
Spine Planning (3.0)
K262257 · OLO
Brainlab SE
Orthopedic · 90d
Cleared Sep 29, 2026
NeckTune™ SA Cervical Cage
K262726 · OVE
Medyssey Co, Ltd.
Orthopedic · 60d
Cleared CT Sep 29, 2026
Spinalogic Bone Growth Stimulator
K262721 · LOF
Djo, LLC
Orthopedic · 60d
Cleared Sep 28, 2026
Alians Forearm
K262649 · HRS
Newclip Technics
Orthopedic · 60d
Cleared Sep 27, 2026
Kentrospine Viktr-MIS® Pedicle screw system
K252139 · NKB
Rivarp Medical Pvt., Ltd.
Orthopedic · 446d
Cleared Sep 25, 2026
Arthrex Beaming System
K262975 · HWC
Arthrex, Inc.
Orthopedic · 30d
Cleared Sep 24, 2026
OsseoFit Stemless Shoulder System
K262955 · PKC
Zimmer, Inc.
Orthopedic · 31d
Cleared Sep 24, 2026
Arthrex Spine Compression FT Screw
K262618 · MRW
Arthrex, Inc.
Orthopedic · 58d
Cleared Sep 24, 2026
corra® cervical plating system
K262149 · KWQ
Carlsmed, Inc.
Orthopedic · 91d
Cleared Sep 24, 2026
Pediatric Nailing Platform Femur
K261345 · HSB
OrthoPediatrics Corp.
Orthopedic · 154d
Cleared Sep 23, 2026
SABER-C System
K263049 · OVE
Elevation Spine
Orthopedic · 23d
Cleared Sep 23, 2026
iFuse Granite Onyx™ Implant System
K262067 · NKB
SI-BONE, Inc.
Orthopedic · 93d
Cleared Sep 23, 2026
ProRib Fixation System
K261892 · HRS
Costa Surgical, Inc.
Orthopedic · 110d