Duns Number:078293017
Device Description: LANCER,SCREW,POLY,REDUCTION,12.5X110
Catalog Number
-
Brand Name
LANCER Pedicle Screw System
Version/Model Number
MT60-125110
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
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
K132049
Product Code
MNH
Product Code Name
Orthosis, spondylolisthesis spinal fixation
Public Device Record Key
ee151ab1-90eb-4bab-9d71-b57b6b9fd41e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 25, 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 | 2373 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5754 |
| U | Unclassified | 61 |