KTW · Class II · 21 CFR 888.3030

FDA Product Code KTW: Appliance, Fixation, Nail/blade/plate Combination, Single Component

Leading manufacturers include Synthes (Usa), Orthofix Srl and Advanced Orthopaedic Solutions, Inc..

38
Total
38
Cleared
88d
Avg days
1978
Since

FDA 510(k) Cleared Appliance, Fixation, Nail/blade/plate Combination, Single Component Devices (Product Code KTW)

38 devices
1–24 of 38
Cleared Jun 20, 2019
PK High Tibial Osteotomy Correction System
K182285
Paonan Biotech Co., Ltd.
Orthopedic · 301d
Cleared Jun 22, 2017
AOS Anterolateral Proximal Humeral Plate
K171606
Advanced Orthopaedic Solutions, Inc. (Aos)
Orthopedic · 21d
Cleared Jun 19, 2017
Phantom Small Bone Intramedullary Nail System
K170693
Paragon 28, Inc.
Orthopedic · 104d
Cleared Mar 15, 2016
AOS Anterolateral Proximal Humeral Plate
K160409
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 28d
Cleared Sep 20, 2012
ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)
K122541
Orthofix Srl
Orthopedic · 30d
Cleared May 06, 2008
AOS PROXIMAL HUMERAL PLATE
K080590
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 64d
Cleared Mar 20, 2008
SYNTHES (USA) MODULAR BLADE PLATE SYSTEM
K080109
Synthes (Usa)
Orthopedic · 65d
Cleared Nov 13, 2006
ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP
K062920
Orthofix Srl
Orthopedic · 46d
Cleared Oct 25, 2002
LEFORTE SYSTEM BONE PLATE
K023360
Jeil Medical Corporation
Orthopedic · 18d
Cleared Jun 24, 2002
REPROCESSED EBI EXTERNAL FIXATION DEVICES
K012645
Alliance Medical Corp.
Orthopedic · 315d
Cleared Sep 06, 2001
SYNTHES LCP PROXIMAL HUMERUS PLATES
K011815
Synthes (Usa)
Orthopedic · 87d
Cleared Aug 02, 2001
SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM
K011458
Synthes (Usa)
Orthopedic · 83d
Cleared May 02, 2001
MODULAR FOOT SYSTEM - 2.7 MM MODULE
K010321
Synthes (Usa)
Orthopedic · 89d
Cleared Aug 04, 2000
STRYKER TRAUMA PELVIC SET
K001614
Howmedica Osteonics Corp.
Orthopedic · 71d
Cleared Jul 14, 2000
SAMARCO SPIDER PLATES
K001271
Biomet, Inc.
Orthopedic · 85d
Cleared Oct 25, 1999
3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP)
K992837
Synthes (Usa)
Orthopedic · 63d
Cleared Jun 29, 1999
OMNI-FIX, HUMERAL NAIL
K991405
Turnkey Intergration USA, Inc.
Orthopedic · 68d
Cleared Apr 01, 1999
OMNI-FIX, NAIL SYSTEM
K990307
Turnkey Intergration USA, Inc.
Orthopedic · 59d
Cleared Sep 14, 1998
CONCISE COMPRESSION HIP SCREW SYSTEM (STERILE)
K982390
Wrightmedicaltechnologyinc
Orthopedic · 67d
Cleared Jun 05, 1997
TRAUMA-FIX EXTERNAL FIXATOR
K971272
Trend Medical, Inc.
Orthopedic · 62d
Cleared Nov 24, 1995
SYNTHES CANNULATED ANGLE BLADE PLATE
K954289
Synthes (Usa)
Orthopedic · 71d
Cleared Apr 05, 1994
MALLEOLAR SCREW
K931686
Onyx Medical Corp.
Orthopedic · 365d
Cleared Jun 01, 1993
TORUS EXTERNAL FIXATION SYSTEM
K925635
Zimmer, Inc.
Orthopedic · 204d
Cleared Nov 29, 1991
ANGLED BLADE PLATE
K914546
Synthes (Usa)
Orthopedic · 49d

About Product Code KTW - Regulatory Context