Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

56 results for "Tornier, Inc."
25–48 of 56
Search insights Median review: 112d Cleared: 100% Top manufacturer: Tornier, Inc. Lead specialty: Orthopedic
Cleared Jul 28, 2015
2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors
K150715 · MBI
Tornier, Inc.
Orthopedic · 131d
Cleared Apr 23, 2015
Aequalis PerFORM+ Shoulder System
K150583 · KWS
Tornier, Inc.
Orthopedic · 45d
Cleared CT Mar 04, 2015
Simpliciti Shoulder System
K143552 · PKC
Tornier, Inc.
Orthopedic · 79d
Cleared Jun 18, 2014
TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM
K141029 · PHX
Tornier, Inc.
Orthopedic · 57d
Cleared Apr 04, 2014
TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR
K133777 · MBI
Tornier, Inc.
Orthopedic · 113d
Cleared Dec 05, 2013
AEQUALIS HUMERAL NAIL
K133376 · HSB
Tornier, Inc.
Orthopedic · 31d
Cleared Sep 19, 2013
TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES
K132632 · MBI
Tornier, Inc.
Orthopedic · 28d
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 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 09, 2012
ASCEND SHOULDER SYSTEM
K113413 · KWS
Tornier, Inc.
Orthopedic · 112d
Cleared Jan 25, 2012
TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD
K111337 · FTL
Tornier, Inc.
General & Plastic Surgery · 258d
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 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