DEVICE: PLEXUR P® (00643169218260)
Device Identifier (DI) Information
PLEXUR P®
60000020
In Commercial Distribution
MEDTRONIC SOFAMOR DANEK, INC.
60000020
In Commercial Distribution
MEDTRONIC SOFAMOR DANEK, INC.
GRANULES 60000020 PLEXUR P 20 CC
Device Characteristics
MR Safe | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
Yes |
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? |
---|---|---|---|---|
61403 | Cadaveric-donor/synthetic polymer bone graft |
A sterile implantable device consisting of processed cadaveric human bone (allograft) mixed with bioabsorbable synthetic polymers, intended to fill bony voids or gaps in the skeletal system (e.g., spine, pelvis, extremities) that have been surgically or traumatically created; it may also serve as a bone graft extender. It is designed to be resorbed/remodelled and replaced by host bone during the healing process. It is available as granules or various solid shapes in a variety of sizes.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MBP | Filler, bone void, osteoinduction (w/o human growth factor) |
MQV | FILLER, BONE VOID, CALCIUM COMPOUND |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K080511 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 20cc volume |
Device Record Status
a87e20b0-ae73-4670-ae15-deaacb6695e4
July 06, 2018
3
July 20, 2015
July 06, 2018
3
July 20, 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 |
---|---|---|---|---|---|
No Package DIs found |
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
[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com