Duns Number:942377524
Device Description: The Integra Movement Great Toe System phalangeal component is designed for resurfacing the The Integra Movement Great Toe System phalangeal component is designed for resurfacing the base of the proximal phalanx. The component is an anatomically designed, monolithic device. The device is made from cobalt chromium alloy with a commerically pure titanium plasma spray. The phalangeal component is intended as hemi-arthroplasty at the surface and is press-fit.
Catalog Number
MGT89030PPH
Brand Name
Integra® MOVEMENT® Great Toe System
Version/Model Number
MGT89030PPH
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
K092047
Product Code
KWD
Product Code Name
PROSTHESIS, TOE, HEMI-, PHALANGEAL
Public Device Record Key
974bfef9-65a7-47a6-b146-2ed310c30bba
Public Version Date
February 21, 2022
Public Version Number
4
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 | 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 |