Duns Number:264255288
Device Description: Trial implant for long Airlock® Lapidus plate - left
Catalog Number
XTI03402
Brand Name
AIRLOCK
Version/Model Number
XTI03402
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
K143523
Product Code
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
ae7ca041-ba3a-4ca1-b3ee-90e010ce82ce
Public Version Date
June 11, 2021
Public Version Number
1
DI Record Publish Date
June 03, 2021
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 | 289 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 494 |