AccessGUDID - DEVICE: ZAVATION VARYISYNC ALIF RASPING TRIAL (00197157067434)

GUDID

Device Identifier (DI) Information

Brand Name: ZAVATION VARYISYNC ALIF RASPING TRIAL
Version or Model: 869-1050-0835-12
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Zavation LLC

Primary DI Number: 00197157067434
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 069472800 *Terms of Use

Device Description: VARYISYNC ALIF RASPING TRIAL 35x12mm

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?
63093	Internal spinal fixation force sensor trial	A copy of a final internal spinal fixation force sensor, typically mounted on a handle, designed to be used to determine availability of adequate space for the fixation of the final temporary sensor used during the implantation procedure of an internal spinal fixation system. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar
ODP	Intervertebral Fusion Device With Bone Graft, Cervical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230731	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: 0187f5e1-d8ac-4388-a7f3-660532296270
Public Version Date: July 17, 2025
Public Version Number: 1
DI Record Publish Date: July 09, 2025