510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161090Substantially Equivalent

Cranial PSI

Ossdsign, Uppsala, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161090 is the FDA 510(k) clearance record for Cranial PSI, a class II device, cleared for Ossdsign AB on under FDA product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable). FDA records list 6 510(k) clearances for Ossdsign AB, from to . As of , FDA records show no recalls naming K161090.

Clearance record

Decision date
Received
(276 days to decision)
Product code
GXN Plate, Cranioplasty, Preformed, Non-Alterable
Regulation
21 CFR 882.5330
Device class
Class II
Review panel
Neurology
Applicant
Ossdsign AB Virdings Alle 2, Uppsala, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXN

Trailing 12 months
6 clearances under product code GXN in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GXN, trailing twelve months
MonthClearances
November 20252
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260