Duns Number:482661753
Device Description: ATP/Lateral Discectomy Instruments Lateral Angled Cobb Elevator Left, Navigable Angled 12. ATP/Lateral Discectomy Instruments Lateral Angled Cobb Elevator Left, Navigable Angled 12.7mm
Catalog Number
289215114
Brand Name
NA
Version/Model Number
289215114
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
K212756
Product Code
OLO
Product Code Name
Orthopedic stereotaxic instrument
Public Device Record Key
8603d3de-593d-4897-a378-45015e8cbef5
Public Version Date
August 17, 2022
Public Version Number
1
DI Record Publish Date
August 09, 2022
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 | 972 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6382 |
| 3 | A medical device with high risk that requires premarket approval | 20 |
| U | Unclassified | 20 |