510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923909Substantially Equivalent

Cement Restrictor for Proforma and Perfecta Total

Orthomet, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923909 is the FDA 510(k) clearance record for CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL, a class II device, cleared for Orthomet, Inc. on under FDA product code LZN (Cement Obturator). FDA records list 60 510(k) clearances for Orthomet, Inc., from to . As of , FDA records show no recalls naming K923909.

Clearance record

Decision date
Received
(92 days to decision)
Product code
LZN Cement Obturator
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Orthomet, Inc. 6301 Cecilia Cir., Minneapolis MN
510(k) summary
Statement
Third party review
No

Clearances, product code LZN

Trailing 12 months

FDA records hold no clearances under product code LZN in the trailing twelve months.

FDA records show no clearances under product code LZN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LZN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260