Duns Number:117630237
Device Description: Apollo Lateral Suture Anchor Delivery System, PEEK Screw, 4.5 x 20mm
Catalog Number
-
Brand Name
Apollo
Version/Model Number
01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 01, 2018
Issuing Agency
In HIBCC
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
-
Product Code
MBI
Product Code Name
Fastener, Fixation, Nondegradable, Soft Tissue
Public Device Record Key
16921e07-6011-471d-ad6a-e02eddda8910
Public Version Date
September 30, 2021
Public Version Number
6
DI Record Publish Date
October 15, 2015
Package DI Number
B048LA45201
Quantity per Package
5
Contains DI Package
B048LA45200
Package Discontinue Date
January 01, 2018
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 90 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 162 |