Duns Number:109903521
Device Description: PERI-LOC 4.5MM ANKLE FUSION PLATE LATERAL TIBIOTALOCALC PERI-LOC 4.5MM ANKLE FUSION PLATE LATERAL TIBIOTALOCALCANEAL RIGHT 120MM STERILE
Catalog Number
72821030S
Brand Name
PERI-LOC ANKLE FUSION PLATING SYSTEM
Version/Model Number
72821030S
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
K110670
Product Code
HRS
Product Code Name
PLATE, FIXATION, BONE
Public Device Record Key
8dfe29c6-152b-40f5-87c3-f64e5c279d21
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 29, 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 | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |