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LXH — Orthopedic Manual Surgical Instrument Class I

FDA Device Classification

Classification Details

Product Code
LXH
Device Class
Class I
Regulation Number
888.4540
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K192873sonex healthSX-One MicroKnifeDecember 20, 2019
K140414orthovitaIMBIBE NEEDLEApril 1, 2014
K101609koros usaSELF RETAINING SOFT TISSUE RETRACTORDecember 9, 2010
K001507smith and nephewMICROPERFORATION INSTRUMENTJune 14, 2000
K952495orthopedic systemsANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEMJanuary 22, 1996
K943873orthometORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SYApril 26, 1995
K944188leibinger l.pSPINAL MARKERApril 13, 1995
K941896depuySTEADMAN LIGAMENT GRAFT PASSER AND PROTECTORNovember 7, 1994
K941711linvatecHYPERFLEX FLEXIBLE GUIDEWIRESAugust 26, 1994
K941605strykerSTRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSHAugust 5, 1994
K933772mahe-medizintechnikPUNCH SURGICALFebruary 1, 1994
K933242danek medicalSOFAMOR ORTHOPAEDIC INSTRUMENTSJanuary 28, 1994
K934260phillips pharmaceuticalsBARRIER BONE WAX APPLICATORJanuary 26, 1994
K931846biomedical devicesBIO-PREPJanuary 21, 1994
K930028thomasville medical assocCALMPS: BONE, MASTIN, LEWIN, BRANDFebruary 16, 1993
K921402macro medicalSURGICAL INSTRUMENT, DISPOSABLEJune 4, 1992
K921644advanced med/surgAMSEN HOCKEY STICK CHISELJune 3, 1992
K921645advanced med/surgAMSEN SPINE IMPACTOR INSTRUMENTSJune 3, 1992
K921642advanced med/surgAMSEN DOUBLE-ENDED FORAMINAL PROBEJune 3, 1992
K921643advanced med/surgAMSEN POSTERIOR DISC EVACUATORJune 3, 1992