Duns Number:942377524
Device Description: The Integra Movement Great Toe System total arthroplasty is an anatomically designed, semi The Integra Movement Great Toe System total arthroplasty is an anatomically designed, semi-constrained, two-piece device designed for resurfacing of the base of the 1st metatarso-phalangeal (MTP) joint. The device uses the metatarsal hemi arthroplasty device paired with a phalangeal base manufactured from titanium with a UHMWPE articulating surface insert. The phalangeal joint replacement device is intended for cemented use.
Catalog Number
MGT89020PPT
Brand Name
Integra® MOVEMENT® Great Toe System
Version/Model Number
MGT89020PPT
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
K102549
Product Code
LZJ
Product Code Name
PROSTHESIS, TOE (METATARSOPHALANGEAL), JOINT, METAL/POLYMER, SEMI-CONSTRAINED
Public Device Record Key
f4057d1e-692f-4bc2-b79c-e4c866576e1d
Public Version Date
February 21, 2022
Public Version Number
5
DI Record Publish Date
September 22, 2015
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 |