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
10897–10920 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 01, 2005
OSTEOCURE RESORBABLE BEAD KIT
K051406 · MQV
Nexa Orthopedics, Inc.
Orthopedic · 62d
Cleared Jul 29, 2005
T2 ANKLE ARTHRODESIS NAIL
K051590 · HSB
Howmedica Osteonics Corp.
Orthopedic · 44d
Cleared Jul 28, 2005
AFT
K042125 · MQV
Musculoskeletal Transplant Foundation
Orthopedic · 356d
Cleared Jul 27, 2005
XIA 4.5 SPINAL SYSTEM
K050461 · MNH
Stryker Spine
Orthopedic · 154d
Cleared Jul 27, 2005
OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES
K050681 · HRS
TriMed, Inc.
Orthopedic · 133d
Cleared Jul 27, 2005
S4 SPINAL SYSTEM
K050979 · MNI
Aesculap, Inc.
Orthopedic · 99d
Cleared Jul 27, 2005
ALEUTIAN SPACER SYSTEM
K051454 · MQP
K2m, LLC
Orthopedic · 55d
Cleared Jul 27, 2005
TRABECULAR METAL REVISION SHELL LINERS
K051516 · JDI
Zimmer, Inc.
Orthopedic · 49d
Cleared Jul 27, 2005
SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM
K051600 · KTT
Synthes (Usa)
Orthopedic · 41d
Cleared Jul 27, 2005
MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ
K051756 · JWH
Zimmer Trabecular
Orthopedic · 28d
Cleared Jul 27, 2005
MALIBU SPINAL SYSTEM
K051942 · KWP
Seaspine, Inc.
Orthopedic · 12d
Cleared Jul 26, 2005
PLC SCREW
K051310 · HWC
Smith & Nephew, Inc.
Orthopedic · 68d
Cleared Jul 22, 2005
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
K051180 · KTT
Vanguard Medical Concepts, Inc.
Orthopedic · 74d
Cleared Jul 21, 2005
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
K050391 · KWP
Globus Medical, Inc.
Orthopedic · 155d
Cleared Jul 21, 2005
OSCAR, MODEL OE3000DB
K051053 · JDX
Orthosonics, Ltd.
Orthopedic · 87d
Cleared Jul 21, 2005
ACUMED RIB CONGRIENT BONE PLATE SYSTEM
K051410 · HRS
Acumed, LLC
Orthopedic · 51d
Cleared Jul 21, 2005
CD HORIZON SPINAL SYSTEM
K051674 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Jul 20, 2005
PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT
K051229 · JWH
Smith & Nephew, Inc.
Orthopedic · 68d
Cleared Jul 20, 2005
MODIFICATION TO SHOULDER FIXATION SYSTEM
K051728 · LXT
Hand Innovations, LLC
Orthopedic · 23d
Cleared Jul 19, 2005
DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES
K050210 · JWH
Biomet, Inc.
Orthopedic · 172d
Cleared Jul 19, 2005
GENEROS SB SMALL BONE DISTRACTION IMPLANT
K051162 · KTT
Orthonetx, Inc.
Orthopedic · 75d
Cleared Jul 19, 2005
HYDRALOK SYSTEM
K051216 · MNH
Altiva Corp.
Orthopedic · 68d
Cleared Jul 19, 2005
ANATOMICAL SHOULDER KEELED GLENOID
K051623 · KWS
Zimmer GmbH
Orthopedic · 29d
Cleared Jul 19, 2005
EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM
K051682 · LZO
Exactech, Inc.
Orthopedic · 26d