DEVICE: NA (10705034787237)
Device Identifier (DI) Information
NA
497.094
In Commercial Distribution
497094
Synthes GmbH
497.094
In Commercial Distribution
497094
Synthes GmbH
TI INFERIOR CRADLE-RIGHT SIZE 7/70MM RADIUS
Device Characteristics
MR Conditional | |
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? |
---|---|---|---|---|
47493 | Vertical expandable prosthetic rib system |
An assembly of implantable devices designed to treat a patient with complex chest wall and/or spinal deformities, typically thoracic insufficiency syndrome (TIS) in paediatric patients (a congenital condition where severe deformities of the chest, spine, and ribs prevent normal breathing and lung growth and development). The assembly typically consists of telescoping rods/bars, fixation hooks, and locking screws/clamps made of surgical stainless steel or titanium (Ti), and are typically vertically attached to the ribs, spine, and/or pelvis to help straighten the spine and separate ribs so that the lungs can grow and fill with sufficient air for breathing.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MDI | Prosthesis, rib replacement |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K142587 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
069e4242-726e-408f-8ccb-02eb7c335dd1
April 27, 2022
4
September 14, 2015
April 27, 2022
4
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 | H9814970940 |
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)255-2500
xx@xx.xx
xx@xx.xx