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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
510(k) Number K902447
Device Name CORING NEEDLE (TREPHINE, ORTHOPEDIC)
Applicant
Biomedtrix, Ltd.
18 Keats Rd.
Scotchtown,  NY  10940
Applicant Contact SIDEBOTHAM
Correspondent
Biomedtrix, Ltd.
18 Keats Rd.
Scotchtown,  NY  10940
Correspondent Contact SIDEBOTHAM
Regulation Number878.4820
Classification Product Code
HWE  
Date Received06/01/1990
Decision Date 08/14/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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