ClearanceBrief
Company · SE

Ossdsign AB

FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2023. Name variants (Inc, Corp, punctuation) are merged.

6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
GXRCover, Burr Hole2
PJNFiller, Bone Void, Non-Alterable Compound For Cranioplasty2
GXNPlate, Cranioplasty, Preformed, Non-Alterable1
MQVFiller, Bone Void, Calcium Compound1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Sep 15, 2023K232315Catalyst Bone Void Filler
Ossdsign AB, IE
MQV
Oct 1, 2021K212414OSSDSIGN Cranial PSI
Ossdsign AB, SE
PJN
Oct 10, 2019K190523Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Access
Ossdsign AB, SE
PJN
Oct 12, 2018K181539OSSDSIGN Cranioplug
Ossdsign AB, SE
GXR
Jan 19, 2017K161090Cranial PSI
Ossdsign AB, SE
GXN
Oct 3, 2014K140309CRANIOPLUG
Ossdsign AB
GXR

Latest recalls

DateFirm and productCodeLinked 510(k)
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