Duns Number:482661753
Device Description: HEALIX TI ANCHOR w/DYNACORD Titanium Anchor (1) Blue (1) White/Blue/Green Striped, Size 2 HEALIX TI ANCHOR w/DYNACORD Titanium Anchor (1) Blue (1) White/Blue/Green Striped, Size 2 (5 Metric), DYNACORD Suture, 36" (91 cm) 6.5mm
Catalog Number
222058
Brand Name
HEALIX TI ANCHOR w/DYNACORD
Version/Model Number
222058
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
K183279
Product Code
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
63a4f8e0-7a43-4905-9554-b5cbae770b10
Public Version Date
October 02, 2020
Public Version Number
1
DI Record Publish Date
September 24, 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 |