AccessGUDID - DEVICE: Xspan Laminoplasty Fixation System (M697X0850306F04RSTR1)

GUDID

Device Identifier (DI) Information

Brand Name: Xspan Laminoplasty Fixation System
Version or Model: X085-0306-F04-R-STR
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Xtant Medical Holdings, Inc.

Primary DI Number: M697X0850306F04RSTR1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081224143 *Terms of Use

Device Description: 6mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK & FIN, 4mm THROAT

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:	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?
46653	Spinal fixation plate, non-bioabsorbable	A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NQW	ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160114	000

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
Depth: 4 Millimeter
Length: 6 Millimeter

Device Record Status

Public Device Record Key: d8ad86d1-6a75-4f27-877a-65c05ed76979
Public Version Date: September 18, 2023
Public Version Number: 6
DI Record Publish Date: April 08, 2016