Duns Number:187502109
Device Description: INTER-LOCK CROSS PIN PLLA - 50MM
Catalog Number
234-015-250
Brand Name
Inter-Lock
Version/Model Number
234-015-250
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 09, 2015
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
K020097
Product Code
JDW
Product Code Name
PIN, FIXATION, THREADED
Public Device Record Key
6b25d585-96bc-4383-8757-1351b19f9584
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 09, 2015
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 | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |