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HTZ — Instrument, Cutting, Orthopedic Class I

FDA Device Classification

FDA product code HTZ covers "Instrument, Cutting, Orthopedic", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification details

Product Code
HTZ
Device Class
Class I
Regulation Number
878.4800
Submission Type
510(k) Exempt
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) clearances

K-NumberApplicantDevice NameDate
K933933Synvasive TechnologyCEBOPLANEApr 15, 1994
K931737Synvasive TechnologyHEDLEYL INTRAMEDULLARY PREPARATION BRUSHJan 7, 1994
K870882Bowen And Company45 DEGREE SHAVERMar 23, 1987
K853678PillingKAMBIN SPINAL INSTRUMENT SETSep 24, 1985
K850423ConceptCONCEPT SUCTION SLEEVEMar 14, 1985
K850527T. Korossurgical InstrumentsARTHROSCOPY SUCTION BIOPSY PUNCHMar 14, 1985
K841980Stainless MfgSIDE CUTTING SERRATED BLADEAug 15, 1984
K842774Codman And ShurtleffCODMAN SUCTION PUNCH-PRODUCT CODESJul 27, 1984
K841975Stainless MfgROSETTE KNIFE 4MMJun 19, 1984
K841973Stainless MfgBANANA KNIFE SERRATEDJun 19, 1984
K841982Stainless MfgMENISCOTOME 4MM & 5MMJun 19, 1984
K841977Stainless Mfg5MM DOUGLE EDGE RING CURETTEJun 19, 1984
K841976Stainless MfgHOOK KNIFE 4MM & 5MMJun 19, 1984
K842111J. Sklar Mfg. CoKOGAN ENDOSPECULUM 9-1/2Jun 19, 1984
K841974Stainless MfgRETROGRADE KNIFE 4MM & 5MMJun 19, 1984
K841972Stainless MfgBANANA KNIFE - K841969-LABELINGJun 19, 1984
K841978Stainless MfgLATERAL RELEASE KNIFE 5MM & 7MMJun 19, 1984
K831772Ortho Pared InstrumentsGUILLOTINE BLADEJul 7, 1983
K771915American SterilizerMICRO OSCILLATING SAWOct 21, 1977
K771005DentronixNEW PODIATRY PRODUCTSJun 17, 1977

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.