AccessGUDID - DEVICE: UCR (10889981028817)

GUDID

Device Identifier (DI) Information

Brand Name: UCR
Version or Model: 10-1011
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-1011
Company Name: Seaspine Orthopedics Corporation

Primary DI Number: 10889981028817
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079840876 *Terms of Use

Device Description: ROD, 5.5 X 110MM. The UCR system contains polyaxial screws of varying reduction height, rods, caps, set screws, crosslinks, crossbars and hooks. Implants are offered in a variety of lengths to accommodate variations in patient anatomy and are manufactured from Titanium 6Aluminum-4Vanadium ELI, with the exception of the Malibu and NewPort Cobalt 28Chromium-6Molybdenum component in the polyaxial screws and the Cobalt35Nickel-20Chromium-10Molybdenum alloy with lower inclusion counts used for some rods and wires.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
65116	Bone-screw internal spinal fixation system rod	An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder 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)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MNH	Orthosis, spondylolisthesis spinal fixation
NKB	Orthosis, spinal pedicle fixation, for degenerative disc disease
MNI	ORTHOSIS, SPINAL PEDICLE FIXATION
KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K043232	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 5.5mm X 110mm Rod

Device Record Status

Public Device Record Key: e3fdb424-74e3-4306-b715-948a280cde9f
Public Version Date: October 24, 2025
Public Version Number: 6
DI Record Publish Date: September 24, 2015