Duns Number:047486041
Device Description: Plate 40mm long. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixatio Plate 40mm long. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
Catalog Number
-
Brand Name
Javelin
Version/Model Number
TB-40-4
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
K202657
Product Code
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
0727dbf9-31f8-41c9-abdc-68451fd95f0b
Public Version Date
November 23, 2021
Public Version Number
2
DI Record Publish Date
February 02, 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 | 461 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1046 |