Duns Number:350354370
Device Description: OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in t OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient’s unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids (510(k) no. K161090)
Catalog Number
101009
Brand Name
OSSDSIGN Cranial PSI
Version/Model Number
M
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
-
Product Code
GXN
Product Code Name
Plate, Cranioplasty, Preformed, Non-Alterable
Public Device Record Key
1518bf77-c5ba-44ab-bfc5-e49df2e1e0c0
Public Version Date
January 23, 2020
Public Version Number
3
DI Record Publish Date
May 11, 2017
Package DI Number
17350086550099
Quantity per Package
1
Contains DI Package
07350086550092
Package Discontinue Date
-
Package Status
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 |