FDA 510(k) Applications for Medical Device Product Code "LXH"
(Orthopedic Manual Surgical Instrument)

FDA 510(k) Number Applicant Device Name Decision Date
K101609 KOROS USA, INC. SELF RETAINING SOFT TISSUE RETRACTOR 12/09/2010
K952495 ORTHOPEDIC SYSTEMS, INC. ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM 01/22/1996
K140414 ORTHOVITA, INC. IMBIBE NEEDLE 04/01/2014
K001507 SMITH & NEPHEW, INC. MICROPERFORATION INSTRUMENT 06/14/2000
K192873 Sonex Health, Inc. SX-One MicroKnife 12/20/2019


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