510(k) K891472

IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR by Implant Technology, Inc. — Product Code LZV

K891472 is an FDA 510(k) premarket notification submitted by Implant Technology, Inc. for the device "IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR". The FDA issued a decision of Substantially Equivalent on May 2, 1989. The device falls under product code LZV (System, Cement Removal Extraction), a Class II device regulated under 21 CFR 888.4580. Implant Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1989
Date Received
March 15, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Cement Removal Extraction
Device Class
Class II
Regulation Number
888.4580
Review Panel
OR
Submission Type