DEVICE: Apollo (B048LA4520TI0)
Device Identifier (DI) Information
Apollo
01
Not in Commercial Distribution
Maruho Medical, Inc.
01
Not in Commercial Distribution
Maruho Medical, Inc.
Apollo Lateral Suture Anchor Delivery System, PEEK Screw, Titanium Punch, 4.5 x 20mm
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 45062 | Tendon/ligament bone anchor, non-bioabsorbable |
A non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].
|
Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
4fbcbafd-4531-457a-a834-3b5709dedceb
April 08, 2021
6
October 15, 2015
April 08, 2021
6
October 15, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| B048LA4520TI1 | 5 | B048LA4520TI0 | 2021-01-01 | Not in Commercial Distribution | Box |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined