Duns Number:190572854
Device Description: PANALOK RC QUICKANCHOR Plus Poly (L-lactide) Absorbable Anchor Size 2 (5 metric) ORTHOCORD PANALOK RC QUICKANCHOR Plus Poly (L-lactide) Absorbable Anchor Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm), double-armed with (2) CP-2 needles.
Catalog Number
212137
Brand Name
PANALOK QUICKANCHOR ORTHOCORD
Version/Model Number
212137
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
K063273
Product Code
JDR
Product Code Name
STAPLE, FIXATION, BONE
Public Device Record Key
ff76088b-919b-4746-b89f-fc08769d0a35
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 |