Duns Number:175899459
Device Description: MAXFRAME Bridging Plate for 5/8 Ring, 240 mm Aluminum
Catalog Number
SYN03.312.440
Brand Name
NA
Version/Model Number
SYN03.312.440
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K161417
Product Code
KTT
Product Code Name
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Public Device Record Key
7aae63f3-65b6-47ee-9082-bbbb63e5f58d
Public Version Date
November 25, 2019
Public Version Number
1
DI Record Publish Date
November 15, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2763 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1372 |
| U | Unclassified | 20 |