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
8785–8808 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 04, 2010
TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET
K093127 · MQP
Zimmer Trabecular Metal Technology
Orthopedic · 153d
Cleared Mar 04, 2010
EVOLUTION MP TOTAL KNEE SYSTEM
K093552 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 107d
Cleared Mar 04, 2010
SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR
K093897 · MBI
Smith & Nephew Inc., Endoscopy Div.
Orthopedic · 76d
Cleared Mar 04, 2010
PASS LP SPINAL SYSTEM
K100297 · MNI
Medicrea Technologies
Orthopedic · 30d
Cleared Mar 03, 2010
SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL
K090658 · KTT
Synthes (Usa)
Orthopedic · 356d
Cleared Mar 03, 2010
DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200
K092331 · KWA
Encore Medical, L.P.
Orthopedic · 211d
Cleared Mar 02, 2010
A-GRIX RESORBABLE BONE VOID FILLER
K091688 · MQV
Ag Digital Technology Corp.
Orthopedic · 265d
Cleared Mar 02, 2010
MEDACTA BIPOLAR HEAD
K091967 · KWY
Medacta International S.A.
Orthopedic · 244d
Cleared Mar 02, 2010
C-MOR VISUALIZATION DEVICE
K093717 · HRX
Axis Surgical Technologies, Inc.
Orthopedic · 90d
Cleared Feb 26, 2010
AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020
K093463 · NDN
Care Fusion
Orthopedic · 112d
Cleared Feb 25, 2010
BINDER INTERVERTEBRAL BODY FUSION DEVICE
K093015 · MAX
Binder Biomedical, Inc.
Orthopedic · 149d
Cleared Feb 24, 2010
POWERPUMP ARTHROSCOPY SYSTEM
K093409 · HRX
Medical Vision AB
Orthopedic · 114d
Cleared Feb 24, 2010
MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA
K093425 · OLO
Mako Surgical Corp.
Orthopedic · 113d
Cleared Feb 23, 2010
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0
K100107 · OLO
Smith & Nephew, Inc.
Orthopedic · 40d
Cleared Feb 19, 2010
HAMMERLOCK
K091951 · HTY
Biomedical Ent., Inc.
Orthopedic · 233d
Cleared Feb 19, 2010
PIONEER POSTERIOR CERVICO-THORACIC SYSTEM
K092295 · KWP
Pioneer Surgical Technology
Orthopedic · 205d
Cleared Feb 19, 2010
NUVASIVE HELIX REVOLUTION ACP SYSTEM
K093804 · KWQ
Nuvasive, Inc.
Orthopedic · 70d
Cleared Feb 19, 2010
OSCAR 3
K093805 · JDX
Orthosonics, Ltd.
Orthopedic · 70d
Cleared Feb 19, 2010
GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS
K100197 · HSX
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Feb 18, 2010
CARRIGEN
K093447 · MQV
Etex Corp.
Orthopedic · 105d
Cleared Feb 17, 2010
REVERE STABILIZATION SYSTEM
K093294 · NKB
Globus Medical, Inc.
Orthopedic · 119d
Cleared Feb 17, 2010
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0
K093533 · MBH
Materialise NV
Orthopedic · 93d
Cleared Feb 17, 2010
EDGELOCK
K093900 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 61d
Cleared Feb 17, 2010
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K100138 · MNI
Alphatec Spine, Inc.
Orthopedic · 29d