DEVICE: NA (10705034764498)
Device Identifier (DI) Information
NA
298.021
Not in Commercial Distribution
298021
SYNTHES (U.S.A.) LP
298.021
Not in Commercial Distribution
298021
SYNTHES (U.S.A.) LP
COLLAR WITH GROOVES FOR 5.0MM RODS
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? |
---|---|---|---|---|
65553 | Spinal bone set screw |
A small, implantable, non-bioabsorbable disc, threaded on its outside surface, intended to be threaded into the internal proximal end of a spinal bone screw head/rod adaptor, anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MNI | ORTHOSIS, SPINAL PEDICLE FIXATION |
MNH | Orthosis, spondylolisthesis spinal fixation |
NKB | Orthosis, spinal pedicle fixation, for degenerative disc disease |
KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
49afaef4-2dca-4302-b9a1-cf1d057c0f11
July 14, 2025
5
September 14, 2015
July 14, 2025
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 | H9812980210 |
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