Duns Number:536935331
Device Description: The Advansys Midfoof Complete set includes Lisfranc plates, Lapidus plates, screws, and in The Advansys Midfoof Complete set includes Lisfranc plates, Lapidus plates, screws, and instruments used to guide the implants, including K-wire. The Lisfranc Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints. It is available in different sizes and is implanted using the locking system fixation screws and washers. Lisfranc Plates are intended for fractures, fusions, osteotomies and replantation of small bones at the tarsometatarsal joints. The Lapidus Plate consists of an osteosynthesis plate designed to bridge the first tarometatarsal joint.
Catalog Number
ADVANMID
Brand Name
Advansys DLP/MLP
Version/Model Number
ADVANMID
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
-
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
K022599,K060474,K060476,K063820,K070241
Product Code
HRS
Product Code Name
PLATE, FIXATION, BONE
Public Device Record Key
5e5dece5-8720-40c6-8dba-c223ef3bf545
Public Version Date
July 16, 2020
Public Version Number
4
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 | 388 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 235 |