Duns Number:190572854
Device Description: RIGIDFIX CURVE ST ACL PEEK Cross Pin System (2) each ST Cross Pins, 3.3mm x 42mm PEEK, (2) RIGIDFIX CURVE ST ACL PEEK Cross Pin System (2) each ST Cross Pins, 3.3mm x 42mm PEEK, (2) each Sleeve Assemblies, (1) each Interlocking Trocar, (1) Pusher Rod, and (1) Bone Gauge Pin
Catalog Number
213015
Brand Name
RIGIDFIX
Version/Model Number
213015
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K130105
Product Code
HTY
Product Code Name
PIN, FIXATION, SMOOTH
Public Device Record Key
c0a9534e-dc3d-4363-85eb-e048391d0179
Public Version Date
March 21, 2019
Public Version Number
5
DI Record Publish Date
September 01, 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 | 560 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 479 |