Duns Number:830350380
Device Description: SPACER 2123545 O25 23.5MM 18 DEG 16X45
Catalog Number
-
Brand Name
PIVOX™ Oblique Lateral Spinal System
Version/Model Number
2123545
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"
Yes
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
K152277
Product Code
KWQ
Product Code Name
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Public Device Record Key
3176e726-21f6-4c4e-9de9-e8bf576fc6ca
Public Version Date
February 24, 2020
Public Version Number
4
DI Record Publish Date
January 20, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13352 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26085 |
| 3 | A medical device with high risk that requires premarket approval | 190 |
| U | Unclassified | 75 |