Duns Number:190572854
Device Description: HEALIX ADVANCE PEEK 3 SUTURE ANCHOR w/ORTHOCORD PEEK Anchor (1) Violet, (1) Blue Strand, ( HEALIX ADVANCE PEEK 3 SUTURE ANCHOR w/ORTHOCORD PEEK Anchor (1) Violet, (1) Blue Strand, (1) Blue Striped, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm) 5.5mm
Catalog Number
222307
Brand Name
HEALIX ADVANCE ORTHOCORD
Version/Model Number
222307
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
K120449
Product Code
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
ccf77ef4-b972-470d-9356-46e8cf7106a4
Public Version Date
March 21, 2019
Public Version Number
5
DI Record Publish Date
September 01, 2015
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 | 560 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 479 |