Duns Number:085503457
Device Description: Additive Orthopaedics Locking Lattice 4 Hole Plate
Catalog Number
-
Brand Name
Additive Orthopaedics Locking Lattice System
Version/Model Number
AOLLPS4H-NL
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
K170214
Product Code
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
8edaaf80-c361-40b0-b712-b429dbcc8dc2
Public Version Date
June 08, 2021
Public Version Number
2
DI Record Publish Date
August 19, 2019
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 49 |