AccessGUDID - DEVICE: Gruve Anterior Cervical Plate System (00190837065164)

GUDID

Device Identifier (DI) Information

Brand Name: Gruve Anterior Cervical Plate System
Version or Model: 158-102
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 158-102
Company Name: Life Spine, Inc.

Primary DI Number: 00190837065164
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 183641617 *Terms of Use

Device Description: Fixation Pin

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?
66937	Spinal intraoperative positioning/manipulation pin, single-use	A nonimplantable rod with an external cylindrical and/or polygonal drive intended to be temporarily introduced, with a dedicated tool (not included), into vertebral bone to: 1) assist with positioning of an implantable device; and/or 2) interface with a surgical instrument (e.g., fixation plate, distractor/retractor) during spinal surgery. It may be threaded; however, as a pin it is designed such that a significant length protrudes from vertebral bone once introduced (i.e., not a positioning screw). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KWQ	Appliance, fixation, spinal intervertebral body

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152282	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: e0b30d3a-7f55-4c14-b9c4-b3dc283f325e
Public Version Date: March 19, 2026
Public Version Number: 3
DI Record Publish Date: November 07, 2019