Duns Number:038023573
Device Description: Cytoflex® Mesh is made of pure implantable Titanium with a precision mesh profile. This pr Cytoflex® Mesh is made of pure implantable Titanium with a precision mesh profile. This product is designed for use to ensure three-dimensional reconstruction of alveolar bone defects and to facilitate bone augmentation through adequate fixation of the augmentation material. The thin, supple mesh conforms easily to tissue contours, and yet presents sufficient stiffness to maintain space over the bony defect.
Catalog Number
C02-4301
Brand Name
Cytoflex Mesh
Version/Model Number
M4-300
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K021511
Product Code
JEY
Product Code Name
Plate, Bone
Public Device Record Key
916f7ab1-42c8-412b-ba70-6b74aeaac453
Public Version Date
July 27, 2021
Public Version Number
4
DI Record Publish Date
November 23, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |
| U | Unclassified | 1 |