DEVICE: DynafitSystem (03701173705606)
Device Identifier (DI) Information
DynafitSystem
I020010
In Commercial Distribution
I020010
NEOSTEO
I020010
In Commercial Distribution
I020010
NEOSTEO
Interphalangeal Joint Fusion Device, Size S, 10°, Sterile
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? |
|---|---|---|---|---|
| 61687 | Phalangeal joint arthrodesis implant |
A small, non-bioabsorbable, implantable device of fixed-length designed to be inserted within a phalangeal joint (i.e., not a plate) in the finger and/or toe (i.e., interphalangeal or phalangeal/metacarpal/metatarsal) to fuse the joint (arthrodesis), typically to manage arthritis or deformities (e.g., hammer toe), or for arthroplasty revision; it is not intended for carpal, tarsal or ankle implantation. It is typically made of metal and can be of several small designs (e.g., rod with barbs at each end, X-shaped, single or dual screw), however it is not intended to be fixed into bone with bone screws (i.e., not an intramedullary nail).
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Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| HWC | Screw, Fixation, Bone |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 15 and 25 Degrees Celsius |
| Special Storage Condition, Specify: Device must be stored in a place protected from light and humidity |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: Size S – 10° |
Device Record Status
0a7cd2b0-ec2c-4c02-b862-6d1d3b973913
March 06, 2025
3
December 15, 2020
March 06, 2025
3
December 15, 2020
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
[?]
No Customer Contact currently defined