Duns Number:942377524
Device Description: The Movement Great Toe System is used for hemi- and total-arthroplasty procedures. The hem The Movement Great Toe System is used for hemi- and total-arthroplasty procedures. The hemi arthroplasty is intended for resurfacing of the 1st metatarsal head or the base of the proximal phalanx. The total arthroplasty is intended for resurfacing of the base of the 1st metatarso-phalangeal joint. This set includes metatarsal, proximal phalanx hemi, and proximal phalanx total trials to evaluate the size and fit of the appropriate implant. Instruments are also included to assist with the trials.
Catalog Number
-
Brand Name
Movement®
Version/Model Number
MOVEMNTINSTP
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K092047,K102549
Product Code
KWD
Product Code Name
PROSTHESIS, TOE, HEMI-, PHALANGEAL
Public Device Record Key
92663a1a-ca3c-48a0-8ba4-825ac8375243
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 15, 2016
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 | 1909 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1404 |
| 3 | A medical device with high risk that requires premarket approval | 12 |
| U | Unclassified | 15 |