Duns Number:963856096
Device Description: The K2 Hemi Toe implant is intended for cement fixation by means of a stem, which is inser The K2 Hemi Toe implant is intended for cement fixation by means of a stem, which is inserted into the medullary canal of the phalanx. It is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Catalog Number
201010
Brand Name
K2™ Hemi Toe Implant System
Version/Model Number
201010
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
K023770
Product Code
KWD
Product Code Name
Prosthesis, Toe, Hemi-, Phalangeal
Public Device Record Key
2b073997-a7f3-4bb3-a735-a23044966560
Public Version Date
February 21, 2022
Public Version Number
5
DI Record Publish Date
October 09, 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 | 1079 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2066 |