Duns Number:486711679
Device Description: ZERO-P NATURAL TRIAL SPACER PARALLEL/LARGE/7MM
Catalog Number
03617037
Brand Name
ZERO-P NATURAL
Version/Model Number
03.617.037
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K152239,K152239
Product Code
KWQ
Product Code Name
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Public Device Record Key
de1edc61-cf6f-4639-b7fe-4b2c5b2e62ef
Public Version Date
May 27, 2022
Public Version Number
5
DI Record Publish Date
February 17, 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 | 8630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16671 |
| U | Unclassified | 2 |