Duns Number:350354370
Device Description: OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OS OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient’s unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set. (510(k) no. K190523)
Catalog Number
-
Brand Name
Anatomical Model Modified
Version/Model Number
XL
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 03, 2020
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K190523,K190523
Product Code
PJN
Product Code Name
Filler, Bone Void, Non-Alterable Compound For Cranioplasty
Public Device Record Key
de5c38b2-d7dd-4f8c-b01e-1252216173ee
Public Version Date
July 03, 2020
Public Version Number
3
DI Record Publish Date
January 22, 2020
Package DI Number
17350086550679
Quantity per Package
1
Contains DI Package
07350086550672
Package Discontinue Date
July 03, 2020
Package Status
Not in Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |