AccessGUDID - DEVICE: MOJAVE Expandable Interbody System (10888857386501)

GUDID

Device Identifier (DI) Information

Brand Name: MOJAVE Expandable Interbody System
Version or Model: 7012-90088
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7012-90088
Company Name: K2M, INC.

Primary DI Number: 10888857386501
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 146060863 *Terms of Use

Device Description: Convex Trial, Size 13x28/32x14 mm

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?
44759	General internal orthopaedic fixation system implantation kit	A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQP	Spinal vertebral body replacement device
ODP	Intervertebral fusion device with bone graft, cervical
MAX	Intervertebral fusion device with bone graft, lumbar

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: 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
Device Size Text, specify: Convex
Length: 32 Millimeter
Height: 14 Millimeter
Width: 13 Millimeter

Device Record Status

Public Device Record Key: 96100486-496f-475e-8c0e-40894a9a6e53
Public Version Date: September 25, 2023
Public Version Number: 3
DI Record Publish Date: March 05, 2018