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

Isometer

21 CFR 888.1520 / Orthopedic
FDA source (opens on fda.gov)

LZE is the FDA product code for Isometer, a class I device type, regulated under 21 CFR 888.1520. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
LZE
Device name
Isometer
Regulation
21 CFR 888.1520
Device class
Class I
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
1
Ingested recalls
0

Clearances, product code LZE

By decision year
1 clearance under product code LZE with a decision year between 1995 and 1995, 1995 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LZE by decision year
YearClearances
19951

Applicants with the most clearances

Product code LZE
Applicants holding the most 510(k) clearances under product code LZE
ApplicantClearances
Pharma-Plast Intl. A/S1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code LZE.