DEVICE: YUKON OCT Spinal System (10888857313262)
Device Identifier (DI) Information
YUKON OCT Spinal System
7601-73515S
In Commercial Distribution
7601-73515S
K2M, INC.
7601-73515S
In Commercial Distribution
7601-73515S
K2M, INC.
Lateral Offset Connector Side 15 mm
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? |
---|---|---|---|---|
65114 | Bone-screw internal spinal fixation system connector |
An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
NKG | Orthosis, cervical pedicle screw spinal fixation |
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 |
---|
Length: 15 Millimeter |
Outer Diameter: 3.5 Millimeter |
Device Record Status
a3b629bd-30bd-45f3-884c-d5538596e3dd
September 11, 2024
6
August 25, 2017
September 11, 2024
6
August 25, 2017
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
[?]
+1(571)919-2000
mark.zellers@stryker.com
mark.zellers@stryker.com