Duns Number:079544913
Device Description: The Bioabsorbable Anchor is an absorbable implant device that is intended to provide fixat The Bioabsorbable Anchor is an absorbable implant device that is intended to provide fixation of a prosthetic material to soft tissue and/or bone. The Bioabsorbable Anchor is composed of polydioxanone dyed with D&C Violet No. 2. Two each of the Bioabsorbable Anchors are provided sterile for single-use only and are packaged preloaded in a single anchor inserter instrument, the Dual Anchor Inserter, in a dual sterile pouch configuration.
Catalog Number
TR-0001-21
Brand Name
Dual Anchor Inserter with Bioabsorbable Anchors
Version/Model Number
TR-0001-21
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
K213958
Product Code
MAI
Product Code Name
Fastener, Fixation, Biodegradable, Soft Tissue
Public Device Record Key
606645d0-77d2-4af0-a133-91771865902b
Public Version Date
May 17, 2022
Public Version Number
1
DI Record Publish Date
May 09, 2022
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |