510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LZVClass II

System, Cement Removal Extraction

21 CFR 888.4580 / Orthopedic
FDA source (opens on fda.gov)

LZV is the FDA product code for System, Cement Removal Extraction, a class II device type, regulated under 21 CFR 888.4580. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LZV
Device name
System, Cement Removal Extraction
Regulation
21 CFR 888.4580
Device class
Class II
Review panel
Orthopedic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
0

Clearances, product code LZV

By decision year
7 clearances under product code LZV with a decision year between 1989 and 2002, 1989 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LZV by decision year
YearClearances
19892
19902
19941
19961
20021

Applicants with the most clearances

Product code LZV
Applicants holding the most 510(k) clearances under product code LZV
ApplicantClearances
Origin Medsystems, Inc.2
Albert K. Chin1
Implant Technology, Inc.1
Orthosonics, Ltd.1
Sonokinetics, Inc.1
Stryker Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code