Duns Number:429763668
Device Description: The implantable device Elite SPK is intended for the attachment of soft tissue to bone dur The implantable device Elite SPK is intended for the attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tears. The implant device is packaged with previously cleared sutures, in their final sterilized form
Catalog Number
A000115
Brand Name
Elite SPK Kit
Version/Model Number
A000115
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
K160500
Product Code
MBI
Product Code Name
Fastener, Fixation, Nondegradable, Soft Tissue
Public Device Record Key
631d6b86-e748-42d7-8344-df1df242f7ff
Public Version Date
March 21, 2019
Public Version Number
5
DI Record Publish Date
December 23, 2016
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |