Duns Number:600664454
Device Description: The SuperBall Meniscal Repair System is a single patient, single use, an all-inside, all-s The SuperBall Meniscal Repair System is a single patient, single use, an all-inside, all-suture meniscal repair device.
Catalog Number
SBD-SB-12-001
Brand Name
SuperBall
Version/Model Number
B
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K180191
Product Code
GAT
Product Code Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Public Device Record Key
00dfcce4-f33e-42ff-8394-7bd3ff18ef2d
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
June 15, 2020
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. | 1 |