Duns Number:054205979
Device Description: 7° (7°/0°), 29H Implant
Catalog Number
-
Brand Name
Spira-V Open Matrix Corpectomy Cage
Version/Model Number
SPV-12145-0729
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
K173800
Product Code
MQP
Product Code Name
Spinal Vertebral Body Replacement Device
Public Device Record Key
4bd6f960-b145-48e3-8502-4a974ca441bf
Public Version Date
February 05, 2020
Public Version Number
2
DI Record Publish Date
July 27, 2018
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. | 2262 |