Duns Number:482661753
Device Description: HEALIX ADVANCE SP BIOCOMPOSITE ANCHOR TCP/PLLA Absorbable Anchor 6.5mm
Catalog Number
222426
Brand Name
HEALIX ADVANCE
Version/Model Number
222426
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
K201883
Product Code
MAI
Product Code Name
Fastener, fixation, biodegradable, soft tissue
Public Device Record Key
0d8c5653-27d6-40ce-88c2-46d13234eed9
Public Version Date
September 11, 2020
Public Version Number
1
DI Record Publish Date
September 03, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 972 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6382 |
| 3 | A medical device with high risk that requires premarket approval | 20 |
| U | Unclassified | 20 |