Duns Number:041956211
Device Description: HANDLE, GUIDES, OFFSET ANGLED
Catalog Number
07-K01-5200
Brand Name
MATIRA ANTERIOR CERVICAL SYSTEM
Version/Model Number
07-K01-5200
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
-
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
LXH
Product Code Name
Orthopedic Manual Surgical Instrument
Public Device Record Key
1b8d1d88-eed0-4b28-b8ed-3a2b67c19ddc
Public Version Date
April 06, 2020
Public Version Number
5
DI Record Publish Date
October 31, 2017
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 | 1286 |
2 | A medical device with a moderate to high risk that requires special controls. | 1900 |