Duns Number:536935331
Device Description: The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve f The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis of the lesser toes in case of rigid or semi-rigid hammertoe deformity, revision of failed arthroplasty or arthrodesis, and shortening due to length excess of the second toe. The implant configuration is available in two different sizes and is manufactured from Stainless Steel. It is delivered sterile.
Catalog Number
230002SND
Brand Name
IPP-ON
Version/Model Number
230002SND
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"
Yes
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
K103623
Product Code
HTY
Product Code Name
PIN, FIXATION, SMOOTH
Public Device Record Key
1e78a709-fe36-4112-9ebe-2fdd42b27434
Public Version Date
July 06, 2018
Public Version Number
3
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 | 388 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 235 |