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

119 results for "Tornier"
49–72 of 119
Search insights Median review: 112d Cleared: 99% Top manufacturer: Tornier, Inc. Lead specialty: Orthopedic
Cleared May 17, 2013
SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS
K130533 · HSN
Tornier S.A.S.
Orthopedic · 77d
Cleared May 13, 2013
TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR
K122635 · MAI
Tornier, Inc.
Orthopedic · 257d
Cleared Apr 04, 2013
PHANTOM FIBER BIOFIBER SUTURE
K130422 · NWJ
Tornier, Inc.
General & Plastic Surgery · 43d
Cleared Jan 08, 2013
AEQUALIS ASCEND FLEX SHOULDER SYSTEM
K122698 · KWS
Tornier S.A.S.
Orthopedic · 126d
Cleared Sep 17, 2012
BIOFIBER SYTURE
K122487 · NWJ
Tornier, Inc.
General & Plastic Surgery · 33d
Cleared Jul 25, 2012
HLS UNI EVOLUTION & U-KNEETEC
K120262 · HSX
Tornier, Inc.
Orthopedic · 180d
Cleared Jul 05, 2012
AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM
K120739 · PHX
Tornier, Inc.
Orthopedic · 115d
Cleared Jun 20, 2012
ASCEND SHOULDER SYSTEM
K121493 · KWS
Tornier, Inc.
Orthopedic · 30d
Cleared Apr 13, 2012
ASCEND SHOULDER SYSTEM
K120794 · KWS
Tornier, Inc.
Orthopedic · 29d
Cleared Mar 13, 2012
AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS,...
K112144 · PHX
Tornier
Orthopedic · 231d
Cleared Mar 09, 2012
ASCEND SHOULDER SYSTEM
K113413 · KWS
Tornier, Inc.
Orthopedic · 112d
Cleared Feb 23, 2012
KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT
K111970 · KRR
Tornier
Orthopedic · 227d
Cleared Jan 25, 2012
TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD
K111337 · FTL
Tornier, Inc.
General & Plastic Surgery · 258d
Cleared Nov 03, 2011
AEQUALIS SHOULDER SYSTEM
K111902 · KWS
Tornier
Orthopedic · 121d
Cleared Oct 11, 2011
AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
K112615 · PHX
Tornier, Inc.
Orthopedic · 33d
Cleared Jun 14, 2011
AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
K110599 · PHX
Tornier, Inc.
Orthopedic · 104d
Cleared Jun 02, 2011
TORNIER INSITE FT SUTURE ANCHOR
K110773 · MBI
Tornier, Inc.
Orthopedic · 73d
Cleared May 10, 2011
TORNIER BIOFIBER SCAFFOLD
K102788 · FTL
Tornier, Inc.
General & Plastic Surgery · 228d
Cleared May 05, 2011
HLS KNEETEC SYSTEM
K094013 · JWH
Tornier
Orthopedic · 492d
Cleared Apr 27, 2011
AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
K110865 · KWS
Tornier, Inc.
Orthopedic · 29d
Cleared Apr 05, 2011
QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM
K103262 · MBI
Tornier, Inc.
Orthopedic · 152d
Cleared Jan 31, 2011
AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
K102924 · KWS
Tornier, Inc.
Orthopedic · 123d
Cleared Nov 09, 2010
AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM
K103007 · KWS
Tornier, Inc.
Orthopedic · 28d
Cleared Jun 29, 2010
LATITUDE ELBOW PROSTHESIS
K100562 · JDB
Tornier, Inc.
Orthopedic · 120d