AccessGUDID - DEVICE: Ø6.5mm x 35mm Pedicle Micro Reduction Screw with Set Screw Package (B064XM22565351)

GUDID

Device Identifier (DI) Information

Brand Name: Ø6.5mm x 35mm Pedicle Micro Reduction Screw with Set Screw Package
Version or Model: XM-225-6535
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: XENCO MEDICAL LLC

Primary DI Number: B064XM22565351
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079282130 *Terms of Use

Device Description: Update: SETX Ø6.5mm x 35mm Cannulated Micro Extended Pedicle Screw with Set Screw

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
61324	Bone-screw internal spinal fixation system, sterile	An assembly of 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. Sterile disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation 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: 8897ecbc-a640-45bb-bef5-b9501c745c60
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: November 03, 2015