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
2809–2832 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 23, 2021
Navigated Spine Instruments
K203205 · OLO
Stryker Spine
Orthopedic · 144d
Cleared Mar 19, 2021
SPINEART Navigation Instrument System
K210472 · OLO
Spineart
Orthopedic · 30d
Cleared Mar 19, 2021
BonOs HV Genta, BonOs MV Genta, BonOs LV Genta
K210125 · LOD
Osartis GmbH
Orthopedic · 59d
Cleared Mar 19, 2021
BonOs HV, BonOs MV, BonOs LV
K210120 · LOD
Osartis GmbH
Orthopedic · 59d
Cleared Mar 18, 2021
Persona Revision Knee System
K210551 · JWH
Zimmer, Inc.
Orthopedic · 21d
Cleared Mar 18, 2021
Infinity™ OCT System, PASS OCT® Spinal System
K210449 · NKG
Medtronic
Orthopedic · 30d
Cleared Mar 18, 2021
Cure 2.0 Anterior Cervical Plate (ACP) System
K210286 · KWQ
Meditech Spine, LLC
Orthopedic · 44d
Cleared Mar 18, 2021
Adaptable Ortho Innovations Intramedullary Nail System
K210285 · HSB
Adaptable Ortho Innovations, LLC
Orthopedic · 44d
Cleared Mar 18, 2021
Automatic Registration
K203679 · OLO
Brainlab AG
Orthopedic · 91d
Cleared Mar 18, 2021
BEE HA Cage
K203444 · ODP
NGMedical GmbH
Orthopedic · 115d
Cleared Mar 18, 2021
CONSTRUX Mini Ti Spacer System
K203342 · ODP
Orthofix, Inc.
Orthopedic · 125d
Cleared Mar 17, 2021
ProLift Wedge Expandable Spacer System
K203361 · MAX
Life Spine, Inc.
Orthopedic · 121d
Cleared Mar 15, 2021
DB-Composite
K210193 · MQV
Dimensional Bioceramics, LLC
Orthopedic · 49d
Cleared Mar 12, 2021
CoLink Mfx Implant System
K210060 · HRS
In2bones USA, LLC
Orthopedic · 60d
Cleared Mar 12, 2021
BC Reflex Uni Knee System
K203697 · HSX
Bodycad Laboratories, Inc.
Orthopedic · 84d
Cleared Mar 11, 2021
Stryker ProCinch Adjustable Loop Device
K210078 · MBI
Stryker Endoscopy
Orthopedic · 58d
Cleared Mar 10, 2021
Hexanium TLIF
K210359 · MAX
Spinevision, S.A.S.
Orthopedic · 30d
Cleared Mar 10, 2021
Lumbar Spine Truss System Plating Solution (LSTS-PS)
K203065 · KWQ
4Web, Inc.
Orthopedic · 152d
Cleared Mar 10, 2021
PROPHECY Preoperative Navigation Alignment System
K202815 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 167d
Cleared Mar 08, 2021
Versalock Periprosthetic Femur Plates System-GMReis
K201728 · HRS
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 258d
Cleared Mar 06, 2021
Apex 3D Total Ankle Replacement System
K210390 · HSN
Paragon 28, Inc.
Orthopedic · 25d
Cleared Mar 05, 2021
Republic Spine Dark Star Spinal System
K201420 · NKB
Republic Spine, LLC
Orthopedic · 280d
Cleared Mar 03, 2021
LOQTEQ Distal Lateral Femur Plate 4.5 System
K210043 · HRS
Aap Implantate AG
Orthopedic · 55d
Cleared Mar 03, 2021
FORZA Ti Spacer System
K203576 · MAX
Orthofix, Inc.
Orthopedic · 86d