DEVICE: NA (20886982131918)
Device Identifier (DI) Information
NA
08.025.044S
In Commercial Distribution
08025044S
Synthes GmbH
08.025.044S
In Commercial Distribution
08025044S
Synthes GmbH
RESORBABLE SLEEVE FOR 5.0MM ANGULAR STABLE LCKNG SCR-STER
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
45041 | Internal orthopaedic fixation system, plate/screw, bioabsorbable |
An assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). It may also include instruments for the attachment of the implants such as screwdrivers or drills.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K090241 | 000 |
K172157 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 5 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
4e4c7d86-4121-4848-92b7-ccea660480f4
February 19, 2024
5
September 14, 2015
February 19, 2024
5
September 14, 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 |
---|---|
HIBCC | H67908025044S0 |
Unit of Use DI
[?]
Unit of Use DI Number:
80886982131910
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)255-2500
xx@xx.xx
xx@xx.xx