Duns Number:146220269
Device Description: Plantar Flexion Stop with Toe Stilt (pair)- articulated ankle joint attached to Ponseti AF Plantar Flexion Stop with Toe Stilt (pair)- articulated ankle joint attached to Ponseti AFO, L1971 and L3380 x 2AFO-PFS SIZE 9 TS PAIR GRAY
Catalog Number
-
Brand Name
MD Orthopaedics
Version/Model Number
AFO-9-PRW-PFS-TS
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KNP
Product Code Name
Orthosis, Corrective Shoe
Public Device Record Key
debdb704-aad4-45fd-a5e5-b0b976667bd4
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
October 05, 2020
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 | 356 |