DEVICE: ORTHROS (B030ORO7575R0)

Download: XML | JSON

Device Identifier (DI) Information

ORTHROS
ORO-7575R

CAMBER SPINE TECHNOLOGIES, LLC
B030ORO7575R0
HIBCC
1
Ø7.5mm polyaxial reduction pedicle screw , 75mm lg.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Polymeric spinal fusion cage, non-sterile A non-sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included. This device must be sterilized prior to use.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KWQ Appliance, Fixation, Spinal Intervertebral Body
MNH Orthosis, Spondylolisthesis Spinal Fixation
MNI Orthosis, Spinal Pedicle Fixation
NKB Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 7.5 Millimeter
Length: 75 Millimeter
CLOSE

Device Status

In Commercial Distribution
November 03, 2016

CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
1-866-643-0739
customerservice@cambermedtech.com
CLOSE