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
6481–6504 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 15, 2014
CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW
K140952 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 31d
Cleared May 14, 2014
NEOPLATE SPINE ANTERIOR FIXATION SYSTEM
K132653 · KWQ
Neoortho Productos Orthopedicos S/A
Orthopedic · 261d
Cleared May 14, 2014
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
K133153 · MNH
Spinefrontier, Inc.
Orthopedic · 209d
Cleared May 14, 2014
SALVATION OSTEOPENIC SCREW
K140408 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 85d
Cleared May 14, 2014
MULTIFIX S KNOTLESS FIXATION SYSTEM
K140604 · MBI
ArthroCare Corporation
Orthopedic · 65d
Cleared May 14, 2014
MSP METATARSAL SHORTENING SYSTEM
K140724 · HRS
Nextremity Solutions, Inc.
Orthopedic · 54d
Cleared May 13, 2014
DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE
K140622 · HRS
Biomet, Inc.
Orthopedic · 63d
Cleared May 13, 2014
ONE-PIECE PEEK FUSION IMPLANT
K140970 · HWC
Mtp Solutions, LLC
Orthopedic · 27d
Cleared May 12, 2014
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
K133378 · PHX
Zimmer, Inc.
Orthopedic · 189d
Cleared May 08, 2014
STALIF C(R)
K133200 · OVE
Centinel Spine, Inc.
Orthopedic · 203d
Cleared May 08, 2014
AAP LOQTEC(R) OLECRANON PLATE
K140607 · HRS
Aap Implantate AG
Orthopedic · 59d
Cleared May 07, 2014
TRUE SPINAL FUSSION SYSTEM
K133690 · MNH
Innovative Surgical Designs
Orthopedic · 156d
Cleared May 07, 2014
EXCELLA III-D SPINAL DEFORMITY SYSTEM
K140238 · NKB
Innovasis, Inc.
Orthopedic · 97d
Cleared May 07, 2014
EVOS MINI-FRAGMENT PLATING SYSTEM
K140814 · HRS
Smith & Nephew, Inc.
Orthopedic · 36d
Cleared May 06, 2014
RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6
K140904 · PHX
Encore Medical, L.P.
Orthopedic · 27d
Cleared May 05, 2014
INFILL CERVICAL
K140066 · ODP
Pinnacle Spine Group, LLC
Orthopedic · 115d
Cleared May 02, 2014
MATRIXRIB FIXATION SYSTEM
K133616 · HRS
Synthes USA Products, LLC
Orthopedic · 158d
Cleared May 01, 2014
STABILIZATION SCREW
K131920 · HWC
In2bones Sas
Orthopedic · 309d
Cleared May 01, 2014
INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM
K133418 · MAX
Seaspine, Inc.
Orthopedic · 175d
Cleared May 01, 2014
XCAGE INTERBODY FUSION SYSTEM
K133514 · MAX
Ouroboros Medical
Orthopedic · 167d
Cleared May 01, 2014
ORTHOPEDIC FIXATION SYSTEMS
K140216 · HRS
Impact Medical, LLC
Orthopedic · 93d
Cleared Apr 29, 2014
GENERAL SPINAL SYSTEM
K140229 · MNI
Tianjin Walkman Biomaterial Co., Ltd.
Orthopedic · 89d
Cleared Apr 28, 2014
ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM
K133653 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 152d
Cleared Apr 25, 2014
OCTANE ELEVATE SPINAL IMPLANT SYSTEM
K123607 · MAX
Exactech, Inc.
Orthopedic · 520d