510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212414Substantially Equivalent

OSSDSIGN Cranial PSI

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

K212414 is the FDA 510(k) clearance record for OSSDSIGN Cranial PSI, a class II device, cleared for Ossdsign AB on under FDA product code PJN (Filler, Bone Void, Non-Alterable Compound For Cranioplasty). FDA's definition for product code PJN reads: "A nonalterable cranial bone void filler is a device that is created from patient-specific computerized tomography (CT) imaging data and intended to fill bony voids, defects, and contour irregularities in non-load bearing regions of the...". FDA records list 6 510(k) clearances for Ossdsign AB, from to . As of , FDA records show no recalls naming K212414.

Clearance record

Decision date
Received
(59 days to decision)
Product code
PJN Filler, Bone Void, Non-Alterable Compound For Cranioplasty
Regulation
21 CFR 882.5330
Device class
Class II
Review panel
Neurology
Applicant
Ossdsign AB Rapsgatan 23 A, Uppsala, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PJN

Trailing 12 months

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

FDA records show no clearances under product code PJN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PJN, 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