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
1729–1752 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 22, 2023
CUVIS-spine
K223558 · OLO
Curexo, Inc.
Orthopedic · 206d
Cleared Jun 20, 2023
CODA™ Anterior Cervical Plate System
K230993 · KWQ
Pioneer Surgical Technology, Inc...
Orthopedic · 75d
Cleared Jun 20, 2023
BethaLoc® stem cementless HA
K223103 · LZO
Implantcast GmbH
Orthopedic · 263d
Cleared Jun 16, 2023
Smart Correction System (HA Half Pins)
K231461 · KTT
Wishbone Medical, Inc.
Orthopedic · 28d
Cleared Jun 16, 2023
Solar Lumbar Interbody Fusion System
K231199 · MAX
Degen Medical
Orthopedic · 50d
Cleared Jun 16, 2023
NuVasive Modulus ALIF System
K230894 · OVD
Nu Vasive, Incorporated
Orthopedic · 77d
Cleared Jun 15, 2023
Xerxes Hip Stem
K231109 · LZO
Xerxes Arthopedix, LLC
Orthopedic · 57d
Cleared Jun 15, 2023
Zevo Anterior Cervical Plate System
K231090 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 59d
Cleared Jun 15, 2023
EDEN Spinal Fixation MIS System
K230762 · NKB
Jmt Co., Ltd.
Orthopedic · 87d
Cleared Jun 14, 2023
TRIGEN META-NAIL Nail System
K230761 · JDS
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Jun 14, 2023
Zavation ALIF System
K230731 · OVD
Zavation Medical Products, LLC
Orthopedic · 90d
Cleared Jun 13, 2023
Axis Anterior Cervical Plate System
K231145 · KWQ
Southern Medical (Pty) , Ltd.
Orthopedic · 53d
Cleared Jun 13, 2023
OptiVu™ ROSA® MxR
K230567 · SBF
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 104d
Cleared Jun 12, 2023
Cut Screw - Percutaneous Compression Screw
K230397 · HWC
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 118d
Cleared Jun 09, 2023
RODIN™ Expandable Lumbar Cage System
K231359 · MAX
Ctl Medical Corporation
Orthopedic · 30d
Cleared Jun 09, 2023
MyKnee UNI-ST
K231037 · JWH
Medacta International S.A.
Orthopedic · 58d
Cleared Jun 09, 2023
Fixone Biocomposite Anchor
K230892 · MAI
Aju Pharm Co., Ltd.
Orthopedic · 70d
Cleared Jun 09, 2023
Acumed Acutrak 3 Headless Compression Screw System
K230744 · HWC
Acumed, LLC
Orthopedic · 84d
Cleared Jun 09, 2023
Gamma4 System
K230512 · HSB
Stryker GmbH
Orthopedic · 105d
Cleared Jun 08, 2023
XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System,...
K222684 · NKB
Stryker Spine
Orthopedic · 275d
Cleared Jun 07, 2023
Fix2Lock(PEEK Self Punching)
K231322 · MBI
Osteonic Co., Ltd.
Orthopedic · 30d
Cleared Jun 07, 2023
Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot...
K231002 · MBI
Suzhou Endophix Co., Ltd.
Orthopedic · 61d
Cleared Jun 07, 2023
AETOS Shoulder System
K230572 · KWS
Smith & Nephew, Inc.
Orthopedic · 98d
Cleared Jun 07, 2023
TiLink-L SI Joint Fusion System
K230446 · OUR
SurGenTec, LLC
Orthopedic · 106d