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
8137–8160 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 06, 2011
OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM
K111326 · HRS
Graham Medical Technologies, LLC
Orthopedic · 56d
Cleared Jul 06, 2011
PLATEAU SPACER SYSTEM
K111569 · MAX
Life Spine
Orthopedic · 30d
Cleared Jul 06, 2011
VIPER SYSTEMS
K111571 · NKB
Johnson & Johnson
Orthopedic · 30d
Cleared Jul 05, 2011
NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT
K110925 · MQV
Novabone Products, LLC
Orthopedic · 95d
Cleared Jul 05, 2011
TOTAL SHOULDER SYSTEM
K111596 · KWS
Shoulder Innovations, LLC
Orthopedic · 27d
Cleared Jul 01, 2011
ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR...
K110940 · KRO
Zimmer, Inc.
Orthopedic · 88d
Cleared Jul 01, 2011
TRIGEN LOW PROFILE BONE SCREW
K111025 · HSB
Smith & Nephew, Inc.
Orthopedic · 79d
Cleared Jul 01, 2011
U2 HIP SYSTEM
K111546 · LPH
United Orthopedic Corp.
Orthopedic · 28d
Cleared Jun 30, 2011
OCTANE-C INTERBODY FUSION DEVICE SYSTEM
K103655 · ODP
Exactech, Inc.
Orthopedic · 197d
Cleared Jun 30, 2011
ZYSTON ARC INTERBODY SPACER
K110650 · MAX
Biomet Spine (Aka Ebi, LLC)
Orthopedic · 118d
Cleared Jun 29, 2011
CORIN MINIHIP FEMORAL STEM
K111046 · LZO
Corin USA
Orthopedic · 75d
Cleared Jun 28, 2011
IVAS 2-10MM (10 GUAGE) BALLON CATHETER
K103807 · NDN
Stryker Corporation
Orthopedic · 181d
Cleared Jun 28, 2011
APTUS FOOT 3.5 SYSTEM
K110908 · HRS
Medartis AG
Orthopedic · 89d
Cleared Jun 27, 2011
CONSENSUS KNEE SYSTEM
K110950 · MBH
Consensus Orthopedics, Inc.
Orthopedic · 84d
Cleared Jun 27, 2011
APEX ARC HIP STEM
K111193 · LZO
Omni Life Science, Inc.
Orthopedic · 60d
Cleared Jun 24, 2011
SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK)
K110545 · MBI
Smith & Nephew, Inc.
Orthopedic · 119d
Cleared Jun 22, 2011
ALEUTIAN SPACER SYSTEM
K110843 · MAX
K2m, Inc.
Orthopedic · 89d
Cleared Jun 22, 2011
APEX PS KNEE SYSTEM - PS-C INSERT
K111184 · JWH
Omni Life Science, Inc.
Orthopedic · 56d
Cleared Jun 22, 2011
UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION
K111444 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 29d
Cleared Jun 21, 2011
GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)
K110805 · OBT
Orthofix, Inc.
Orthopedic · 90d
Cleared Jun 20, 2011
NUVASIVE LONG LATERAL SPINAL SYSTEM
K111410 · KWQ
Nuvasive, Inc.
Orthopedic · 32d
Cleared Jun 17, 2011
ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM
K111086 · HRS
OrthoPediatrics Corp.
Orthopedic · 59d
Cleared Jun 16, 2011
APEX K1 HIP STEM
K110947 · LPH
Omni Life Science, Inc.
Orthopedic · 73d
Cleared Jun 16, 2011
MAXFIRE MARXMEN MENISCAL REPAIR DEVICE
K111564 · MBI
Biomet Sports Medicine
Orthopedic · 10d