Duns Number:830350380
Device Description: SPACER 5001622 CONTROL PTC 6 DEG 16X22
Catalog Number
-
Brand Name
Capstone Control PTC Spinal System
Version/Model Number
5001622
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K171107
Product Code
MAX
Product Code Name
Intervertebral fusion device with bone graft, lumbar
Public Device Record Key
64e2ad68-63b3-4f69-aed9-38fabff089db
Public Version Date
October 02, 2018
Public Version Number
1
DI Record Publish Date
September 01, 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 |
|---|---|---|
| 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 |