Duns Number:482661753
Device Description: PEEK Anchor with (1) 2.5mm Blue PERMATAPE Braided Flat Suture, 38 inches (96cm) and (1) Wh PEEK Anchor with (1) 2.5mm Blue PERMATAPE Braided Flat Suture, 38 inches (96cm) and (1) White/Black, Size 2 (5 metric) PERMACORD Braided Suture, 36 inches (91cm), (1) Utility Shuttle Suture
Catalog Number
222365
Brand Name
HEALIX ADVANCE PEEK ANCHOR w/PERMATAPE PERMACORD
Version/Model Number
222365
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K170639
Product Code
MBI
Product Code Name
Fastener, fixation, nondegradable, soft tissue
Public Device Record Key
96ab1b9c-eff9-42db-bb51-0a567ccabdeb
Public Version Date
March 21, 2019
Public Version Number
6
DI Record Publish Date
October 27, 2017
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 |