DEVICE: SYNFIX Evolution (10705034814094)
Device Identifier (DI) Information
SYNFIX Evolution
03.835.003
In Commercial Distribution
03835003
Synthes GmbH
03.835.003
In Commercial Distribution
03835003
Synthes GmbH
SYNFIX® EVOLUTION AIMING DEVICE/17MM & 19MM
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
61929 | Orthopaedic implant aiming/guiding block attachment tool |
A manually-operated surgical instrument intended to be used to attach an orthopaedic implant aiming/guiding block to an implant (e.g., orthopaedic plate) to facilitate implantation. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OVD | Intervertebral fusion device with integrated fixation, lumbar |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K150673 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3f92cc3c-7644-4a9d-9673-c0b0ce496313
September 01, 2023
5
June 30, 2016
September 01, 2023
5
June 30, 2016
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 | H981038350030 |
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