OSSDSIGN Cranial PSI— 510(k) K212414

Substantially Equivalent

Ossdsign AB

FDA 510(k) clearance K212414 for OSSDSIGN Cranial PSI, Substantially Equivalent on 2021-10-01. Applicant: Ossdsign AB. Device class: 2.

Clearance details

Applicant: Ossdsign AB
Product code: Code PJN
Device class: Class 2
Regulation: 21 CFR 882.5330
Advisory panel: Neurology
Date received: 2021-08-03
Decision date: 2021-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uppsala, SE

Download summary PDF View on FDA.gov ↗

Recent devices under product code PJN

K190523 — Cranial PSI Accessory Anatomical Model Original, Cranial PSI Accessory Anatomical Model Modified, Cranial PSI Accessory Plastic Drawing Guide, Cranial PSI Accessory Cranial Implant Trial2019-10-10

More clearances from Ossdsign AB

K232315 — Catalyst Bone Void Filler2023-09-15
K181539 — OSSDSIGN Cranioplug2018-10-12
K161090 — Cranial PSI2017-01-19
K140309 — CRANIOPLUG2014-10-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.