FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,766 results
2737–2760 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Not Cleared Dec 16, 2020
BEAR (Bridge-Enhanced ACL Repair) Implant
DEN200035 · QNI
Miach Orthopaedics, Inc.
Orthopedic · 195d
Cleared Dec 15, 2020
NEXXT MATRIXX Stand Alone ALIF System
K202230 · OVD
Nexxt Spine, LLC
Orthopedic · 130d
Cleared Dec 15, 2020
WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA...
K201755 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 169d
Cleared Dec 15, 2020
Fixone All Suture Anchor
K192709 · MBI
Aju Pharm Co., Ltd.
Orthopedic · 445d
Cleared Dec 14, 2020
Javelin Tailor's Bunion Fixation System
K202657 · HRS
Nvision Biomedical Technologies, Inc.
Orthopedic · 91d
Cleared Dec 14, 2020
Physica system
K201084 · MBH
Lima Corporate S.P.A.
Orthopedic · 235d
Cleared Dec 11, 2020
ELEOS Limb Salvage System featuring BIOGRIP
K203090 · JDI
Onkos Surgical
Orthopedic · 59d
Cleared Dec 11, 2020
GMK Total Knee System - TiNbN Coating
K202684 · JWH
Medacta International S.A.
Orthopedic · 87d
Cleared Dec 10, 2020
MY01 Continuous Compartmental Pressure Monitor
K202635 · LXC
MY01, Inc.
Orthopedic · 90d
Cleared Dec 10, 2020
PROFEMUR® GLADIATOR® Cemented Classic Stem
K201519 · JDI
Microport Orthopedics, Inc.
Orthopedic · 185d
Cleared Dec 10, 2020
Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral...
K200376 · OLO
Navbit Pty, Ltd.
Orthopedic · 296d
Cleared Dec 10, 2020
Posterior Fusion Plate, HA Posterior Fusion Plate
K200066 · PEK
Spinal Simplicity, LLC
Orthopedic · 332d
Cleared Dec 10, 2020
Zimmer Segmental System
K192798 · KRO
Zimmer, Inc.
Orthopedic · 437d
Cleared Dec 08, 2020
CD Horizon Spinal System Instruments
K203291 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Dec 08, 2020
Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator,...
K201253 · KTT
Smith & Nephew
Orthopedic · 211d
Cleared Dec 08, 2020
Accu-Joint Hemi Implant
K200951 · KWD
Accufix Surgical, Inc.
Orthopedic · 243d
Cleared Dec 08, 2020
Taperloc® Complete Hip Stems
K200196 · LZO
Biomet Orthopedics
Orthopedic · 316d
Cleared Dec 04, 2020
LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System
K200789 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 253d
Cleared Dec 03, 2020
LineSider™ Spinal System
K203367 · NKB
Integrity Implants, Inc.
Orthopedic · 17d
Cleared Dec 03, 2020
NuVasive ACP System
K203253 · KWQ
Nu Vasive, Incorporated
Orthopedic · 29d
Cleared Dec 03, 2020
aprevo Intervertebral Body Fusion Device
K202034 · MAX
Carlsmed, Inc.
Orthopedic · 133d
Cleared Dec 02, 2020
SMS Cementless Stem
K203041 · LZO
Medacta International S.A.
Orthopedic · 57d
Cleared Dec 02, 2020
Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161
K201072 · KYI
Ensemble Orthopedics, LLC
Orthopedic · 224d
Cleared Dec 02, 2020
NuVasive Navigation.S Instruments
K200719 · OLO
Nu Vasive, Incorporated
Orthopedic · 258d