AccessGUDID - DEVICE: NEO Modera Pedicle Screw System (00815730020484)

GUDID

Device Identifier (DI) Information

Brand Name: NEO Modera Pedicle Screw System
Version or Model: A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3RCC55-50
Company Name: NEW ERA ORTHOPEDICS LLC

Primary DI Number: 00815730020484
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079375910 *Terms of Use

Device Description: Rod, Curved, Co-Cr, Ø5.5mm x 50mm

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:	Yes
Prescription Use (Rx):	No
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?
37272	Trans-facet-screw internal spinal fixation system, sterile	A sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MNI	Orthosis, Spinal Pedicle Fixation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141253	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
No Device Sizes

Device Record Status

Public Device Record Key: aca18fa2-7b76-473e-b928-544f405a0622
Public Version Date: May 14, 2020
Public Version Number: 5
DI Record Publish Date: September 20, 2016