510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010840Substantially Equivalent

Synplug

Isotis NV, North Attleboro MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K010840 is the FDA 510(k) clearance record for SYNPLUG, a class II device, cleared for Isotis NV on under FDA product code LZN (Cement Obturator). FDA records list 8 510(k) clearances for Isotis NV, from to . As of , FDA records show no recalls naming K010840.

Clearance record

Decision date
Received
(30 days to decision)
Product code
LZN Cement Obturator
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Isotis NV 49 Plain St., North Attleboro MA
510(k) summary
Summary
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