Duns Number:350354370
Device Description: OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinforced with a OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinforced with a titanium mesh plate which together provide the mechanical performance, safety and efficacy properties. The fully cured calcium phosphate ceramic fills the void in the burr hole. The osteoconductive ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is sized to match standard 11mm and 14mm burr hole perforators. (510(k) no. K181539)
Catalog Number
-
Brand Name
OSSDSIGN Cranioplug
Version/Model Number
11 mm, 6 fixation-points
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
GXR
Product Code Name
Cover, Burr Hole
Public Device Record Key
60af97f6-bdb6-4914-a3cd-f247cc6d919c
Public Version Date
May 21, 2021
Public Version Number
4
DI Record Publish Date
June 05, 2019
Package DI Number
17350086550259
Quantity per Package
10
Contains DI Package
07350086550252
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 |