Duns Number:963856096
Device Description: The Integra Compact Cranial Closer System bone plates and screws are made of pure titanium The Integra Compact Cranial Closer System bone plates and screws are made of pure titanium and titanium alloy with screw diameters from 1.5mm to 1.8mm and lengths from 3.0mm to 5.0mm. The system offers the operating room surgeon unique features and user friendly capabilities. This device is intended for use in selective trauma of cranial skeleton, cranial surgery and reconstructive procedures.
Catalog Number
CRANCLOSIMP
Brand Name
Integra® Compact Cranial Closure System
Version/Model Number
CRANCLOSIMP
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 12, 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
-
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
K112812
Product Code
GWO
Product Code Name
Plate, Cranioplasty, Preformed, Alterable
Public Device Record Key
4fb533c3-48f3-4bed-bd91-0a2d7d32b9da
Public Version Date
September 14, 2020
Public Version Number
6
DI Record Publish Date
August 15, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1079 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2066 |