AccessGUDID - DEVICE: Spike Driver, 5-7mm (00810017913541)

GUDID

Device Identifier (DI) Information

Brand Name: Spike Driver, 5-7mm
Version or Model: CI-DRIVER3-SP-567
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CI-DRIVER3-SP-567
Company Name: ELEVATION SPINE, INC.

Primary DI Number: 00810017913541
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 085718404 *Terms of Use

Device Description: Spike Driver, 5-7mm

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?
61300	Internal spinal fixation procedure kit, single-use	A collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ODP	Intervertebral Fusion Device With Bone Graft, Cervical
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical
KWQ	Appliance, Fixation, Spinal Intervertebral Body

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190885	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 0d5073e1-da72-4de6-9ad1-fd0ca08dee9b
Public Version Date: July 17, 2025
Public Version Number: 4
DI Record Publish Date: January 18, 2024