DEVICE: NA (10705034751849)
Device Identifier (DI) Information
NA
04.651.440
In Commercial Distribution
04651440
SYNTHES (U.S.A.) LP
04.651.440
In Commercial Distribution
04651440
SYNTHES (U.S.A.) LP
5.5MM TI MIN INVASIVE STRAIGHT ROD 40MM
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? |
---|---|---|---|---|
61325 | Bone-screw internal spinal fixation system, non-sterile |
An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
NKB | Orthosis, spinal pedicle fixation, for degenerative disc disease |
KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
MNH | Orthosis, spondylolisthesis spinal fixation |
MNI | ORTHOSIS, SPINAL PEDICLE FIXATION |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K093668 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
6e5ab4bd-773b-43b2-9b7f-997348bf159b
July 06, 2018
3
September 14, 2015
July 06, 2018
3
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 | H981046514400 |
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